Trial Outcomes & Findings for A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies (NCT NCT02520427)

NCT ID: NCT02520427

Last Updated: 2024-07-31

Results Overview

A participant was not DLT-evaluable if they dropped out before completion of the DLT window (14 days) for reasons other than an adverse event related to study drug or the participant had not received investigational product (IP) treatment for at least 14 days at the target dose for a 3- or 4-week cycle or at least 7 days at a target dose for a 2- week cycle. Furthermore, following drug interruptions, if a participant was unable to complete 2 repeat cycles for reasons other than DLT, the participant was not DLT evaluable.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 95 participants
• Primary outcome timeframe: Day 1 to Day 14
• Results posted on: 2024-07-31

Participant Flow

Participants were enrolled at 9 research centers in the United States, Germany and the Netherlands and participated in the trial from August 2015 to December 2021.

95 participants were enrolled and received treatment.

Participant milestones

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Overall Study STARTED	1	1	3	3	3	3	4	4	4	3	4	7	3	3	6	3	5	4	5	8	4	2	4	3	4	1
Overall Study COMPLETED	0	1	2	3	3	3	4	4	3	2	4	7	2	2	5	3	2	3	2	3	2	2	3	3	3	1
Overall Study NOT COMPLETED	1	0	1	0	0	0	0	0	1	1	0	0	1	1	1	0	3	1	3	5	2	0	1	0	1	0

Reasons for withdrawal

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Overall Study Decision by sponsor	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	1	0	0	0	0	0	0	0	0	0	1	1	1	0	1	0	0	3	2	0	0	0	0	0
Overall Study Death	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	3	2	0	0	1	0	1	0

Baseline Characteristics

A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

Baseline characteristics by cohort

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=7 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day n=6 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day n=8 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day n=4 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day n=2 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day n=4 Participants Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 n=3 Participants Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 n=4 Participants Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 n=1 Participants Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Total n=95 Participants Total of all reporting groups
Age, Customized 18-64 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	3 Participants n=36 Participants	2 Participants n=36 Participants	4 Participants n=24 Participants	2 Participants n=135 Participants	3 Participants n=136 Participants	3 Participants n=44 Participants	3 Participants n=667 Participants	4 Participants n=7 Participants	2 Participants n=6 Participants	2 Participants n=10 Participants	2 Participants n=14 Participants	2 Participants n=4 Participants	3 Participants n=4 Participants	0 Participants n=4 Participants	58 Participants n=26 Participants
Age, Customized 65-74 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	2 Participants n=24 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	1 Participants n=44 Participants	1 Participants n=667 Participants	3 Participants n=7 Participants	2 Participants n=6 Participants	0 Participants n=10 Participants	2 Participants n=14 Participants	1 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	31 Participants n=26 Participants
Age, Customized 75-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	6 Participants n=26 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	2 Participants n=24 Participants	1 Participants n=135 Participants	3 Participants n=136 Participants	2 Participants n=44 Participants	2 Participants n=667 Participants	3 Participants n=7 Participants	1 Participants n=6 Participants	1 Participants n=10 Participants	1 Participants n=14 Participants	2 Participants n=4 Participants	3 Participants n=4 Participants	0 Participants n=4 Participants	42 Participants n=26 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=36 Participants	2 Participants n=36 Participants	4 Participants n=24 Participants	2 Participants n=135 Participants	2 Participants n=136 Participants	2 Participants n=44 Participants	3 Participants n=667 Participants	5 Participants n=7 Participants	3 Participants n=6 Participants	1 Participants n=10 Participants	3 Participants n=14 Participants	1 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=4 Participants	53 Participants n=26 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	1 Participants n=44 Participants	1 Participants n=667 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=10 Participants	1 Participants n=14 Participants	1 Participants n=4 Participants	2 Participants n=4 Participants	0 Participants n=4 Participants	16 Participants n=26 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	3 Participants n=36 Participants	3 Participants n=36 Participants	5 Participants n=24 Participants	3 Participants n=135 Participants	4 Participants n=136 Participants	3 Participants n=44 Participants	4 Participants n=667 Participants	8 Participants n=7 Participants	4 Participants n=6 Participants	1 Participants n=10 Participants	3 Participants n=14 Participants	2 Participants n=4 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	79 Participants n=26 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=26 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	3 Participants n=26 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	1 Participants n=24 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	1 Participants n=44 Participants	1 Participants n=667 Participants	0 Participants n=7 Participants	1 Participants n=6 Participants	1 Participants n=10 Participants	1 Participants n=14 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	16 Participants n=26 Participants
Race/Ethnicity, Customized Black (or African American)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	4 Participants n=26 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=26 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	7 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	5 Participants n=24 Participants	2 Participants n=135 Participants	4 Participants n=136 Participants	2 Participants n=44 Participants	4 Participants n=667 Participants	6 Participants n=7 Participants	2 Participants n=6 Participants	1 Participants n=10 Participants	3 Participants n=14 Participants	2 Participants n=4 Participants	2 Participants n=4 Participants	1 Participants n=4 Participants	69 Participants n=26 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	1 Participants n=6 Participants	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants n=26 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 14

Population: DLT-evaluable Analysis Set: All DLT-evaluable participants.

A participant was not DLT-evaluable if they dropped out before completion of the DLT window (14 days) for reasons other than an adverse event related to study drug or the participant had not received investigational product (IP) treatment for at least 14 days at the target dose for a 3- or 4-week cycle or at least 7 days at a target dose for a 2- week cycle. Furthermore, following drug interruptions, if a participant was unable to complete 2 repeat cycles for reasons other than DLT, the participant was not DLT evaluable.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=6 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day n=3 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day n=2 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day n=3 Participants Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 n=2 Participants Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 n=4 Participants Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days

Population: Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 330.

The severity of TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria. The general guideline for assessment ranged from Grade 1 to 5, with higher grades indicating a worse outcome, and included: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=7 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day n=6 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day n=8 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day n=4 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day n=2 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day n=4 Participants Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 n=3 Participants Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 n=4 Participants Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 n=1 Participants Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) All TEAEs	1 Participants	1 Participants	3 Participants	3 Participants	3 Participants	3 Participants	4 Participants	4 Participants	4 Participants	3 Participants	4 Participants	7 Participants	3 Participants	3 Participants	6 Participants	3 Participants	5 Participants	4 Participants	5 Participants	8 Participants	4 Participants	2 Participants	4 Participants	3 Participants	4 Participants	1 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade 4	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants	4 Participants	1 Participants	0 Participants	3 Participants	2 Participants	4 Participants	4 Participants	3 Participants	5 Participants	1 Participants	2 Participants	4 Participants	2 Participants	1 Participants	1 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade 5	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade 1	1 Participants	1 Participants	2 Participants	3 Participants	2 Participants	3 Participants	4 Participants	4 Participants	4 Participants	3 Participants	4 Participants	7 Participants	3 Participants	3 Participants	6 Participants	3 Participants	5 Participants	4 Participants	5 Participants	7 Participants	4 Participants	2 Participants	4 Participants	3 Participants	4 Participants	1 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade 2	1 Participants	1 Participants	2 Participants	3 Participants	3 Participants	3 Participants	4 Participants	4 Participants	4 Participants	3 Participants	4 Participants	6 Participants	3 Participants	3 Participants	6 Participants	3 Participants	5 Participants	4 Participants	5 Participants	8 Participants	4 Participants	2 Participants	4 Participants	3 Participants	4 Participants	1 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade 3	1 Participants	1 Participants	2 Participants	3 Participants	3 Participants	3 Participants	4 Participants	4 Participants	2 Participants	3 Participants	4 Participants	6 Participants	3 Participants	2 Participants	5 Participants	3 Participants	4 Participants	3 Participants	5 Participants	8 Participants	3 Participants	2 Participants	4 Participants	3 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline until the end of study, up to approximately 6 months

Number of participants with a binding anti-body positive result at any timepoint post-baseline who had a negative or no result at baseline.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=7 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day n=6 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day n=7 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day n=4 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day n=2 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day n=4 Participants Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 n=3 Participants Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 n=4 Participants Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 n=1 Participants Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Number of Participants Who Experienced an Incident of Anti-AMG 330 Antibody Formation	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of IP (Day 1) until the end of study, up to approximately 6 months

Response for participants with R/R AML was defined as the percentage of participants with complete response (CR)/complete remission with incomplete count recovery (CRi)/morphologic leukemia-free state (MLFS) [per modified international working group (IWG) criteria] or complete remission with partial hematologic recovery (CRh).

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=7 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day n=6 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day n=5 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day n=8 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day n=3 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day n=4 Participants Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day n=1 Participants Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Response Rate in Participants With R/R AML	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 97.5	100.0 Percentage of participants 95% Confidence Interval 2.5 • Interval 2.5 to 100.0	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 60.2	25.0 Percentage of participants 95% Confidence Interval 0.6 • Interval 0.6 to 80.6	25.0 Percentage of participants 95% Confidence Interval 0.6 • Interval 0.6 to 80.6	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	25.0 Percentage of participants 95% Confidence Interval 0.6 • Interval 0.6 to 80.6	14.3 Percentage of participants 95% Confidence Interval 0.4 • Interval 0.4 to 57.9	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	33.3 Percentage of participants 95% Confidence Interval 4.3 • Interval 4.3 to 77.7	33.3 Percentage of participants 95% Confidence Interval 0.8 • Interval 0.8 to 90.6	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 52.2	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 60.2	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 52.2	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 36.9	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 60.2	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 97.5	—	—	—

SECONDARY outcome

Timeframe: From first dose of IP (Day 1) until the end of study, up to approximately 6 months

Response for participants with MRD-positive AML was defined as the percentage of participants with a conversion from MRD+ status with 0.1% threshold to CRMDR- or CRiMD-.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Response Rate in Participants With MRD-positive AML	25.0 Percentage of participants 95% Confidence Interval 0.6 • Interval 0.6 to 80.6	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 84.2	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of IP (Day 1) until the end of study, up to approximately 6 months

Response for participants with MDS was defined as the percentage of participants with CR or marrow complete remission per IWG.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Response Rate in Participants With MDS	25.0 Percentage of participants 95% Confidence Interval 0.6 • Interval 0.6 to 80.6	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of IP (Day 1) until the end of study, up to approximately 6 months

Population: Per the Statistical Analysis Plan, duration of response was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion.

Duration of response was defined as the interval from the date of the first disease assessment indicating an overall response to the first documented relapse, disease progression, or death due to any cause, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of IP (Day 1) until the end of study, up to approximately 6 months

Population: Per the Statistical Analysis Plan, time to response was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion.

Time to response was defined as the interval from the first administration of AMG 330 to the first documentation of response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of IP (Day 1) until the end of study, up to approximately 6 months

Population: Per the Statistical Analysis Plan, event-free survival was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion.

Event-free survival was defined as the interval from first administration of AMG 330 to the earliest of date of treatment failure, relapse for responders, or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline until the end of study, up to approximately 6 months

Population: Per the Statistical Analysis Plan, overall survival was only planned to be measured in the expansion cohorts. Therefore, this endpoint was not summarized due to early termination of the trial prior to dose expansion.

Overall survival was defined as the time from enrollment until death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 day infusion duration: Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days)

Population: Includes all participants who had analyzable samples.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
14 Day Infusion Duration: Terminal Half Life (t1/2 z) of AMG 330	—	—	2.68 hours Full Range 2.68 • Interval 2.68 to 2.68	3.28 hours Full Range 2.90 • Interval 2.9 to 4.48	—	4.03 hours Full Range 2.59 • Interval 2.59 to 4.3	5.34 hours Full Range 5.05 • Interval 5.05 to 5.62	8.07 hours Full Range 8.07 • Interval 8.07 to 8.07	7.34 hours Full Range 7.20 • Interval 7.2 to 7.49	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 days)

Population: Includes all participants who had analyzable samples.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
28 Day Infusion Duration: t1/2 z of AMG 330	8.34 Hours Full Range 8.34 • Interval 8.34 to 8.34	6.49 Hours Full Range 6.49 • Interval 6.49 to 6.49	—	4.57 Hours Full Range 4.47 • Interval 4.47 to 4.67	5.03 Hours Full Range 4.37 • Interval 4.37 to 8.07	4.96 Hours Full Range 4.96 • Interval 4.96 to 4.96	8.67 Hours Full Range 7.71 • Interval 7.71 to 9.18	3.71 Hours Full Range 3.21 • Interval 3.21 to 4.22	4.99 Hours Full Range 2.58 • Interval 2.58 to 5.41	3.80 Hours Full Range 2.90 • Interval 2.9 to 4.71	9.14 Hours Full Range 9.14 • Interval 9.14 to 9.14	4.22 Hours Full Range 3.32 • Interval 3.32 to 5.13	6.43 Hours Full Range 6.30 • Interval 6.3 to 7.34	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days)

Population: Includes all participants who had analyzable samples.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
14 Day Infusion Duration: Steady State Serum Concentration After End of Infusion (Css) of AMG 330	0.00 ng/mL Full Range 0.00 • Interval 0.0 to 0.0	0.0231 ng/mL Full Range 0.0231 • Interval 0.0231 to 0.0231	0.0541 ng/mL Full Range 0.0378 • Interval 0.0378 to 0.0608	0.158 ng/mL Full Range 0.0856 • Interval 0.0856 to 0.29	0.221 ng/mL Full Range 0.220 • Interval 0.22 to 0.221	0.155 ng/mL Full Range 0.134 • Interval 0.134 to 0.234	0.325 ng/mL Full Range 0.240 • Interval 0.24 to 0.41	0.610 ng/mL Full Range 0.390 • Interval 0.39 to 0.83	2.29 ng/mL Full Range 1.16 • Interval 1.16 to 2.52	3.97 ng/mL Full Range 2.97 • Interval 2.97 to 4.96	—	0.952 ng/mL Full Range 0.952 • Interval 0.952 to 0.952	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 days)

Population: Includes all participants who had analyzable samples.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
28 Day Infusion Duration: Css After End of Infusion of AMG 330	0.440 ng/mL Full Range 0.200 • Interval 0.2 to 5.13	1.83 ng/mL Full Range 1.07 • Interval 1.07 to 2.02	1.56 ng/mL Full Range 1.56 • Interval 1.56 to 1.56	5.92 ng/mL Full Range 3.61 • Interval 3.61 to 8.23	5.95 ng/mL Full Range 4.62 • Interval 4.62 to 19.5	7.36 ng/mL Full Range 2.09 • Interval 2.09 to 12.6	3.20 ng/mL Full Range 2.24 • Interval 2.24 to 4.16	24.2 ng/mL Full Range 5.46 • Interval 5.46 to 63.0	7.52 ng/mL Full Range 5.82 • Interval 5.82 to 13.6	1.79 ng/mL Full Range 1.37 • Interval 1.37 to 2.21	8.40 ng/mL Full Range 8.40 • Interval 8.4 to 8.4	1.14 ng/mL Full Range 1.14 • Interval 1.14 to 1.14	—	0.952 ng/mL Full Range 0.952 • Interval 0.952 to 0.952	—	1.76 ng/mL Full Range 0.920 • Interval 0.92 to 2.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days)

Population: Includes all participants who had analyzable samples.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
14 Day Infusion Duration: Volume of Distribution at Steady State (Vz) of AMG 330	—	—	11.9 Liters Full Range 11.9 • Interval 11.9 to 11.9	17.0 Liters Full Range 6.02 • Interval 6.02 to 23.0	—	31.0 Liters Full Range 30.1 • Interval 30.1 to 57.9	62.7 Liters Full Range 49.5 • Interval 49.5 to 76.0	149 Liters Full Range 149 • Interval 149.0 to 149.0	44.1 Liters Full Range 42.9 • Interval 42.9 to 45.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 day)

Population: Includes all participants who had analyzable samples.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
28 Day Infusion Duration: Vz of AMG 330	293 Liters Full Range 293 • Interval 293.0 to 293.0	69.6 Liters Full Range 69.6 • Interval 69.6 to 69.6	—	33.1 Liters Full Range 19.6 • Interval 19.6 to 46.7	47.1 Liters Full Range 9.69 • Interval 9.69 to 58.7	19.8 Liters Full Range 19.8 • Interval 19.8 to 19.8	165 Liters Full Range 107 • Interval 107.0 to 223.0	8.79 Liters Full Range 3.98 • Interval 3.98 to 13.6	63.8 Liters Full Range 18.2 • Interval 18.2 to 89.4	76.6 Liters Full Range 76.3 • Interval 76.3 to 76.8	54.9 Liters Full Range 54.9 • Interval 54.9 to 54.9	105 Liters Full Range 105 • Interval 105.0 to 105.0	60.2 Liters Full Range 46.4 • Interval 46.4 to 98.8	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose to 48 hours from the start of infusion, and days 4, 8, 11, 15, 16 and 22 of Cycle 1 for Group 1 and days 8, 15 and 16 for Group 4 (each cycle was 28 days)

Population: Includes all participants who had analyzable samples.

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
14 Day Infusion Duration: Clearance at Steady State (CL) for AMG 330	—	2.71 L/hr Full Range 2.71 • Interval 2.71 to 2.71	3.08 L/hr Full Range 2.74 • Interval 2.74 to 4.41	2.64 L/hr Full Range 1.44 • Interval 1.44 to 4.87	5.67 L/hr Full Range 5.66 • Interval 5.66 to 5.68	8.06 L/hr Full Range 5.34 • Interval 5.34 to 9.33	8.26 L/hr Full Range 6.10 • Interval 6.1 to 10.4	9.42 L/hr Full Range 6.02 • Interval 6.02 to 12.8	4.37 L/hr Full Range 3.97 • Interval 3.97 to 8.62	5.38 L/hr Full Range 4.03 • Interval 4.03 to 6.73	—	10.5 L/hr Full Range 10.5 • Interval 10.5 to 10.5	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose to 48 hours from the start of infusion, and days 8, 15, 22, 29, and 30 of Cycle 1 (each cycle was 36 days)

Outcome measures

Measure	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=4 Participants Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=2 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=1 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 Participants Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 4: Tocilizumab, Dexamethasone and AMG 330 Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
28 Day Infusion Duration: CL of AMG 330	22.8 L/hr Full Range 1.95 • Interval 1.95 to 50.0	8.20 L/hr Full Range 7.43 • Interval 7.43 to 14.0	12.8 L/hr Full Range 12.8 • Interval 12.8 to 12.8	4.98 L/hr Full Range 3.04 • Interval 3.04 to 6.93	5.04 L/hr Full Range 1.54 • Interval 1.54 to 6.49	9.76 L/hr Full Range 2.77 • Interval 2.77 to 16.7	13.7 L/hr Full Range 9.62 • Interval 9.62 to 17.9	2.23 L/hr Full Range 0.860 • Interval 0.86 to 9.92	8.87 L/hr Full Range 4.90 • Interval 4.9 to 11.5	14.8 L/hr Full Range 11.3 • Interval 11.3 to 18.2	4.17 L/hr Full Range 4.17 • Interval 4.17 to 4.17	21.9 L/hr Full Range 21.9 • Interval 21.9 to 21.9	5.68 L/hr Full Range 5.00 • Interval 5.0 to 10.9	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Group 4: Tocilizumab, Dexamethasone and AMG 330

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 1 - Cohort 1 AMG 330 0.5 µg/Day

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Group 1 - Cohort 2 AMG 330 1.5 µg/Day

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 1 - Cohort 3 AMG 330 4 µg/Day

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 1 - Cohort 4 AMG 330 10 µg/Day

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1 - Cohort 5 AMG 330 30 µg/Day

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1 - Cohort 6 AMG 330 10/30 µg/Day

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1 - Cohort 7 AMG 330 10/60 µg/Day

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 1 - Cohort 8 AMG 330 10/120 µg/Day

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 1 - Cohort 9 AMG 330 10/240 µg/Day

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 1 - Cohort 10 AMG 330 10/480 µg/Day

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day

Serious events: 6 serious events

Other events: 7 other events

Deaths: 0 deaths

Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day

Serious events: 4 serious events

Other events: 5 other events

Deaths: 3 deaths

Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day

Serious events: 4 serious events

Other events: 8 other events

Deaths: 2 deaths

Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Group 4 - Etanercept and AMG 330

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 4 - Etanercept, Dexamethasone and AMG 330

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Group 4: Tocilizumab, Dexamethasone and AMG 330 n=1 participants at risk Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 participants at risk Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 participants at risk Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=7 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day n=6 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day n=5 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day n=5 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day n=8 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day n=4 participants at risk Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day n=2 participants at risk Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day n=4 participants at risk Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 n=3 participants at risk Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 n=4 participants at risk Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Metabolism and nutrition disorders Adult failure to thrive	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac tamponade	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericarditis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular fibrillation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Optic neuropathy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal perforation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Subileus	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Swollen tongue	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Cytokine release syndrome	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Arthritis infective	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacteraemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Device related infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Epstein-Barr virus infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Escherichia bacteraemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Fournier's gangrene	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Mucormycosis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sepsis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Septic shock	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis fungal	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Subcutaneous abscess	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Platelet count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations White blood cell count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Optic neuritis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Seizure	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Measure	Group 4: Tocilizumab, Dexamethasone and AMG 330 n=1 participants at risk Participants with R/R AML received tocilizumab 8 mg/kg IV infusion and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received tocilizumab on Day 1, 1 hour before the 1st dose of AMG 330 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.	Group 1 - Cohort 1 AMG 330 0.5 µg/Day n=1 participants at risk Participants with R/R AML (Group 1) received AMG 330 0.5 µg/day as a 14 day continuous infusion (cIV).	Group 1 - Cohort 2 AMG 330 1.5 µg/Day n=1 participants at risk Participants with R/R AML (Group 1) received AMG 330 1.5 µg/day as a 14 day cIV.	Group 1 - Cohort 3 AMG 330 4 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 4 µg/day as a 14 day cIV.	Group 1 - Cohort 4 AMG 330 10 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 10 µg/day as a 14 day cIV.	Group 1 - Cohort 5 AMG 330 30 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 30 µg/day as a 14 day cIV.	Group 1 - Cohort 6 AMG 330 10/30 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 30 µg/day as a 14 day cIV.	Group 1 - Cohort 7 AMG 330 10/60 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 60 µg/day as a 14 day cIV.	Group 1 - Cohort 8 AMG 330 10/120 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 120 µg/day as a 14 day cIV.	Group 1 - Cohort 9 AMG 330 10/240 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 240 µg/day as a 14 day cIV.	Group 1 - Cohort 10 AMG 330 10/480 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial step dose of 10 µg/day and then the target dose of 480 µg/day as a 14 day cIV.	Group 1 - Cohort 11 AMG 330 10/60/240 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 12 AMG 330 10/60/240 ug/Day n=7 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, then the target dose of 240 µg/day as a 28 day cIV.	Group 1 - Cohort 13 AMG 330 10/60/360 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 360 µg/day as a 28 day cIV.	Group 1 - Cohort 14 AMG 330 10/60/480 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 60 µg/day, and then the target dose of 480 µg/day as a 28 day cIV.	Group 1 - Cohort 15 AMG 330 10/240/600 µg/Day n=6 participants at risk Participants with R/R AML (Group 1) received AMG 330 at an initial daily step dose of 10 µg/day and a second step dose of 240 µg/day, and then the target dose of 600 µg/day as a 28 day cIV.	Group 1 - Cohort 16 AMG 330 10/240/600/720 µg/Day n=3 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 720 µg/day as a 28 day cIV.	Group 1 - Cohort 17 AMG 330 10/240/600/840 µg/Day n=5 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 840 µg/day as a 28 day cIV.	Group 1 - Cohort 18 AMG 330 10/240/600/960 µg/Day n=4 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240 and 600 µg/day and then the target dose of 960 µg/day as a 28 day cIV.	Group 1 - Cohort 19 AMG 330 10/240/600/960/1300 µg/Day n=5 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 240, 600, and 960 µg/day and then the target dose of 1300 µg/day as a 28 day cIV.	Group 1 - Cohort 20 AMG 330 10/60/240/600/960/1600 µg/Day n=8 participants at risk Participants with R/R AML (Group 1) received AMG 330 at initial daily step doses of 10, 60, 240, 600, and 960 µg/day and then the target dose of 1600 µg/day as a 28 day cIV.	Group 2 - Cohort 1 AMG 300 30/240/600 µg/Day n=4 participants at risk Participants with MRD+ AML (Group 2) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 600 µg/day as a 28 day cIV.	Group 2 - Cohort 2 AMG 330 30/240/840 µg/Day n=2 participants at risk Participants with MRD+ AML (Group 2) received AMG 330 at initial step daily doses of 30 µg/day for up to 2 days, 240 µg/day for up to 5 days and then the target dose of 840 µg/day as a 28 day cIV.	Group 3 - Cohort 1 AMG 330 30/240/600 µg/Day n=4 participants at risk Participants with MDS (Group 3) received AMG 330 at initial daily step doses of 30 µg/day for up to 2 days and 240 µg/day for up to 5 days and then the target dose of 600 µg/day for a total of a 28 day cIV.	Group 4 - Etanercept and AMG 330 n=3 participants at risk Participants with R/R AML received etanercept 50 mg as a subcutaneous (SC) injection in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle.	Group 4 - Etanercept, Dexamethasone and AMG 330 n=4 participants at risk Participants with R/R AML received etanercept 50 mg as a SC injection and dexamethsone 8 mg IV infusion in combination with AMG 330. Participants received AMG 330 at initial daily step doses of 10 µg/day for 2 days, 60 µg/day for 3 days and 240 µg/day for 9 days for a total of a 14 day cIV. Participants received etanercept 1 day before first AMG 330 administration and on Day 4 of each cycle. Participants received dexamethasone 1 hour before AMG 330 dose.
Infections and infestations Clostridium difficile infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Amylase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Conjunctivitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Device related infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterococcal infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Staphylococcal infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterocolitis infectious	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Haemorrhoid infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Herpes dermatitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Herpes simplex	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Herpes simplex pharyngitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Kidney infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Localised infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Perineal cellulitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia adenoviral	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia bacterial	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia fungal	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia klebsiella	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Rash pustular	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Streptococcal bacteraemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Vascular device infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural contusion	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural swelling	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound decomposition	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations ADAMTS13 activity decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Antithrombin III decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Alanine aminotransferase	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Antithrombin III increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Aspergillus test positive	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Bacterial test positive	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood bilirubin decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood calcium decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood creatine increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood creatinine increased	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood fibrinogen decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood phosphorus decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood potassium decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood urea increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations C-reactive protein increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Cardiac murmur	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Chest X-ray abnormal	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Creatinine renal clearance decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Electrocardiogram QT prolonged	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Electrocardiogram QT shortened	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Eosinophil count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Glomerular filtration rate decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Haematocrit decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Hepatic enzyme increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Immunoglobulins increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Interleukin level increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations International normalised ratio increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Lipase increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Monocyte count increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Neutrophil count increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Platelet count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Procalcitonin increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Prothrombin time shortened	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Red blood cell count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Serum ferritin increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Troponin I increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Urine output decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Weight increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations White blood cell analysis abnormal	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations White blood cell count decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations White blood cell count increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	80.0% 4/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	37.5% 3/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 3/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Malnutrition	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Protein deficiency	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Memory impairment	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Vitamin B complex deficiency	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Altered state of consciousness	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Aphasia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Bell's palsy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dyskinesia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 3/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	80.0% 4/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Lethargy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Neuralgia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Presyncope	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Seizure	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Somnolence	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Speech disorder	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Syncope	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Tonic clonic movements	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Tremor	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Vocal cord paralysis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Agitation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Bradyphrenia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Bruxism	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Delirium	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Depersonalisation/derealisation disorder	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Depression	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Disorientation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Emotional distress	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Frustration tolerance decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Hallucination	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Panic attack	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Personality change	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Restlessness	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Suicidal ideation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Bladder pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Dysuria	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Hydrocalyx	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Micturition frequency decreased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Nocturia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Pollakiuria	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Polyuria	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Proteinuria	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Nipple pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Perineal pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	37.5% 3/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 4/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	37.5% 3/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Flushing	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	71.4% 5/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 3/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	37.5% 3/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Ischaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Orthostatic hypotension	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Shock	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Thrombophlebitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Thrombosis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 4/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute left ventricular failure	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial tachycardia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block second degree	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericarditis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus bradycardia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tachyarrhythmia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Gilbert's syndrome	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Ear disorder	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Ear pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Hyperthyroidism	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Cataract	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Conjunctival hyperaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Conjunctival irritation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Dry eye	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Eye haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Eye irritation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Eye swelling	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Eyelid oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Glaucoma	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Lacrimation increased	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Ocular hyperaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Orbital oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Periorbital oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Periorbital swelling	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Retinal haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Swelling of eyelid	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Vision blurred	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	37.5% 3/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Anal incontinence	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Ascites	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	83.3% 5/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 4/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Enteritis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Eructation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Faecaloma	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Faeces discoloured	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric disorder	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Glossodynia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haematochezia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal dilatation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal perforation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Lip ulceration	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	42.9% 3/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	80.0% 4/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophagitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oral disorder	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oral pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Periodontal disease	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Retching	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Swollen tongue	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Tongue discomfort	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Tongue haematoma	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 3/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	80.0% 4/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	37.5% 3/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Asthenia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Catheter site haemorrhage	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Catheter site irritation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Catheter site oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Catheter site pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest discomfort	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chills	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Discomfort	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Face oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Facial pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 2/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Gait disturbance	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Generalised oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Infusion site extravasation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Localised oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Malaise	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.0% 2/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Mucosal inflammation	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema mucosal	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema peripheral	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	60.0% 3/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	62.5% 5/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 1/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Peripheral swelling	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	28.6% 2/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Swelling face	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Systemic inflammatory response syndrome	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Temperature intolerance	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Vessel puncture site pain	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	14.3% 1/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatomegaly	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 2/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	20.0% 1/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Liver injury	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Cytokine release syndrome	100.0% 1/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 3/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	50.0% 2/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	85.7% 6/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	83.3% 5/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	66.7% 2/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	80.0% 4/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 5/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	75.0% 6/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 2/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 3/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	100.0% 4/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.5% 1/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Aspergillus infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacteraemia	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacterial infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.7% 1/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 1/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Candida infection	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/1 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	33.3% 1/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/7 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/6 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/5 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/8 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/2 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/3 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4 • Mortality: Day 1 until end of study; median (min, max) time on study was 1.45 (0.26, 7.85) months. Adverse Events: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days Mortality is reported for all participants randomized. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER