Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis (NCT NCT03142191)

Last Updated: 2023-06-28

Results Overview

Mean change from baseline in percentage point difference in % predicted forced vital capacity (FVC) FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

138 participants

Primary outcome timeframe

from baseline to week 24

Results posted on

2023-06-28

Participant Flow

Participants in the placebo arm during treatment period were re-randomized during the active treatment period to receive either CC-90001 200mg or CC-90001 400mg. 1 participant in the active treatment period did not have the end of study form filled out and therefore was listed in the missing row.

Participant milestones

Participant milestones
Measure	CC-90001 200mg (IPF Study) CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) CC-90001 400mg PO QD	Placebo (IPF Study) Placebo	CC-90001 400mg (PPF Sub-Study) CC-90001 400mg PO QD	Placebo (PPF Sub-Study) Placebo
Placebo Controlled Period STARTED	39	37	36	15	8
Placebo Controlled Period COMPLETED	32	28	31	15	7
Placebo Controlled Period NOT COMPLETED	7	9	5	0	1
Active Treatment Extension Period STARTED	31	27	30	15	6
Active Treatment Extension Period CC-90001 200mg	0	0	15	0	3
Active Treatment Extension Period CC-90001 400mg	0	0	15	0	3
Active Treatment Extension Period COMPLETED	5	13	15	3	0
Active Treatment Extension Period NOT COMPLETED	26	14	15	12	6

Reasons for withdrawal

Reasons for withdrawal
Measure	CC-90001 200mg (IPF Study) CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) CC-90001 400mg PO QD	Placebo (IPF Study) Placebo	CC-90001 400mg (PPF Sub-Study) CC-90001 400mg PO QD	Placebo (PPF Sub-Study) Placebo
Placebo Controlled Period Death	0	1	1	0	0
Placebo Controlled Period Adverse Event	4	5	1	0	0
Placebo Controlled Period Progressive Disease	1	0	1	0	0
Placebo Controlled Period Withdrawal by participant	1	3	2	0	1
Placebo Controlled Period Other Reasons	1	0	0	0	0
Active Treatment Extension Period Death	2	1	1	1	0
Active Treatment Extension Period Adverse Event	6	5	4	1	0
Active Treatment Extension Period Progressive Disease	10	5	4	1	2
Active Treatment Extension Period Withdrawal by participant	2	0	3	1	1
Active Treatment Extension Period Physician Decision	2	0	0	0	0
Active Treatment Extension Period Other Reasons	3	3	3	8	3
Active Treatment Extension Period Unknown, participant missing	1	0	0	0	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	CC-90001 400mg (PPF Sub-Study) n=15 Participants CC-90001 400mg PO QD	Placebo (PPF Sub-Study) n=8 Participants Placebo	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	5 Participants n=21 Participants	36 Participants n=10 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	99 Participants n=10 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	35 Participants n=10 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	100 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	33 Participants n=7 Participants	32 Participants n=5 Participants	15 Participants n=4 Participants	8 Participants n=21 Participants	123 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	35 Participants n=7 Participants	35 Participants n=5 Participants	15 Participants n=4 Participants	8 Participants n=21 Participants	131 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants

PRIMARY outcome

Timeframe: from baseline to week 24

Population: Full Analysis Set in IPF Cohort

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). Week 1	0.5 Percentage Point Standard Deviation 3.04	0.6 Percentage Point Standard Deviation 2.87	-0.9 Percentage Point Standard Deviation 3.51	—	—	—	—
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). Week 4	0.3 Percentage Point Standard Deviation 4.65	1.7 Percentage Point Standard Deviation 3.90	-1.4 Percentage Point Standard Deviation 3.75	—	—	—	—
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). Week 8	0.5 Percentage Point Standard Deviation 5.70	2.4 Percentage Point Standard Deviation 3.98	-1.7 Percentage Point Standard Deviation 3.75	—	—	—	—
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). Week 12	-0.6 Percentage Point Standard Deviation 4.83	2.0 Percentage Point Standard Deviation 3.70	-2.5 Percentage Point Standard Deviation 4.57	—	—	—	—
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). Week 16	-1.7 Percentage Point Standard Deviation 5.55	1.0 Percentage Point Standard Deviation 5.27	-2.0 Percentage Point Standard Deviation 4.43	—	—	—	—
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). Week 20	-1.2 Percentage Point Standard Deviation 3.92	0.6 Percentage Point Standard Deviation 4.55	-2.7 Percentage Point Standard Deviation 6.60	—	—	—	—
Percentage Point Difference in % Predicted Forced Vital Capacity (FVC). Week 24	-2.3 Percentage Point Standard Deviation 4.96	-0.5 Percentage Point Standard Deviation 4.77	-2.5 Percentage Point Standard Deviation 4.85	—	—	—	—

SECONDARY outcome

Timeframe: from baseline to week 24

Population: Full Analysis Set participants with evaluable measures in IPF cohort at week 24

Mean change from baseline in absolute FVC in the full analysis set (FAS) population. FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=32 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=29 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=30 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Mean Change From Baseline in Absolute Forced Vital Capacity (FVC).	-74.9 mL Standard Deviation 162.58	-6.8 mL Standard Deviation 170.39	-88.3 mL Standard Deviation 176.80	—	—	—	—

SECONDARY outcome

Timeframe: From baseline up to week 104

Population: Full Analysis Set in the IPF cohort

Mean change in distance walked in the 6-minute Walk Test (6MWT) The 6MWT measures the distance a participant is able to walk on a hard, flat surface, over a total of six minutes. The time points which will be measured are from baseline to Week 24, Extension Week 52, Extension Week 76, Extension Week 104, Week 24 to extension (Ext) Week 52 and Week 24 to Ext Week 104 FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment. Week 24 is the start of baseline of the active treatment extension period.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) Week 24	6.9 meters Standard Deviation 73.42	-21.1 meters Standard Deviation 45.80	-8.1 meters Standard Deviation 49.89	—	—	—	—
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) Extension Week 52	-21.9 meters Standard Deviation 82.57	-15.9 meters Standard Deviation 46.42	—	-30.0 meters Standard Deviation 56.69	-29.1 meters Standard Deviation 94.95	—	—
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) Extension Week 76	-9.7 meters Standard Deviation 58.90	3.7 meters Standard Deviation 46.31	—	14.4 meters Standard Deviation 25.00	-42.7 meters Standard Deviation 92.46	—	—
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) Extension Week 104	-15.3 meters Standard Deviation 95.13	-25.4 meters Standard Deviation 58.73	—	-18.6 meters Standard Deviation 56.24	-38.7 meters Standard Deviation 87.80	—	—
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) Week 24 to Ext Week 52	0.2 meters Standard Deviation 1.02	0.7 meters Standard Deviation 1.25	—	-0.9 meters Standard Deviation 0.88	0.7 meters Standard Deviation 1.59	—	—
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) Week 24 to Ext Week 104	0.0 meters Standard Deviation 1.00	-0.3 meters Standard Deviation 0.42	—	0.6 meters Standard Deviation 1.24	-0.1 meters Standard Deviation 1.66	—	—

SECONDARY outcome

Timeframe: From baseline up to week 104

Population: Full Analysis Set in the IPF cohort

Mean change from baseline in dyspnea rating on Borg Scale after the 6MWT. The Borg scale ranges from 0 to 10. Where 0 is no dyspnea and a 10 is extremely strong dyspnea. The lower the number the better. The time points which will be measured are from baseline to Week 24, Extension Week 52, Extension Week 76, Extension Week 104, Week 24 to extension (Ext) Week 52 and Week 24 to Ext Week 104 FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment. Week 24 is the start of baseline of the active treatment extension period.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Mean Change From Baseline in Dyspnea Rating on Borg Scale Week 24	0.4 Score on a Scale Standard Deviation 1.38	0.1 Score on a Scale Standard Deviation 1.39	0.0 Score on a Scale Standard Deviation 1.55	—	—	—	—
Mean Change From Baseline in Dyspnea Rating on Borg Scale Extension Week 52	0.9 Score on a Scale Standard Deviation 1.32	1.3 Score on a Scale Standard Deviation 1.48	—	0.1 Score on a Scale Standard Deviation 0.68	1.0 Score on a Scale Standard Deviation 1.93	—	—
Mean Change From Baseline in Dyspnea Rating on Borg Scale Extension Week 76	-0.2 Score on a Scale Standard Deviation 1.53	1.2 Score on a Scale Standard Deviation 1.30	—	-0.7 Score on a Scale Standard Deviation 1.30	-0.5 Score on a Scale Standard Deviation 1.52	—	—
Mean Change From Baseline in Dyspnea Rating on Borg Scale Extension Week 104	1.0 Score on a Scale Standard Deviation 3.50	0.6 Score on a Scale Standard Deviation 1.15	—	1.3 Score on a Scale Standard Deviation 0.88	-0.5 Score on a Scale Standard Deviation 1.52	—	—
Mean Change From Baseline in Dyspnea Rating on Borg Scale Week 24 to Ext Week 52	0.7 Score on a Scale Standard Deviation 1.71	1.1 Score on a Scale Standard Deviation 1.53	—	-0.1 Score on a Scale Standard Deviation 0.64	1.5 Score on a Scale Standard Deviation 2.25	—	—
Mean Change From Baseline in Dyspnea Rating on Borg Scale Week 24 to Ext Week 104	1.8 Score on a Scale Standard Deviation 2.57	-0.1 Score on a Scale Standard Deviation 1.02	—	0.3 Score on a Scale Standard Deviation 0.52	0.2 Score on a Scale Standard Deviation 2.25	—	—

SECONDARY outcome

Timeframe: From Baseline up to week 24

Population: Full analysis set in IPF Cohort

Disease progression is defined as one or more of the following: * Death from respiratory failure, * Absolute decrease of ≥ 10% from baseline in % predicted FVC at two consecutive evaluations at a minimum of 4 weeks between evaluations * Decrease from baseline of ≥ 50 meters in 6MWT distance (in the absence of a readily explainable cause, such as injury or trauma). * Unexplained worsening hypoxemia (an absolute decrease from baseline of 4% or more in arterial oxygen saturation by pulse oximetry \[SpO2\]). FAS population is defined as all randomized participants who received at least one dose of the investigational product. Baseline is defined as day 1 of treatment.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Percentage of Participants Who Had Disease Progression	23.1 Percentage of participants	27.0 Percentage of participants	25.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline up to week 24

Population: Full analysis set with evaluable SGRQ measures in IPF Cohort

The SGRQ is a quality of life health questionnaire that has been validated in IPF. It consists of 76 items in three domains: * Symptoms * Activity * Impact of disease on daily life A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment). In addition to the total score, there is also a score for each domain: symptoms, activity, and impact which are scored 0-100. Each component score is derived by dividing the summed weights, unique for all questions, by the maximum possible weight.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=28 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=23 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=27 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) Activity	2.1 Score on a Scale Standard Deviation 16.95	-6.5 Score on a Scale Standard Deviation 12.72	-4.5 Score on a Scale Standard Deviation 13.04	—	—	—	—
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) Impact of disease on daily life	-1.9 Score on a Scale Standard Deviation 19.31	-8.6 Score on a Scale Standard Deviation 19.17	-1.2 Score on a Scale Standard Deviation 20.59	—	—	—	—
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) Symptoms	2.0 Score on a Scale Standard Deviation 21.10	-11.8 Score on a Scale Standard Deviation 17.57	-8.3 Score on a Scale Standard Deviation 20.63	—	—	—	—
Mean Change From Baseline in Total Score and Domains on the Saint George's Respiratory Questionnaire (SGRQ) Total	-0.3 Score on a Scale Standard Deviation 16.84	-8.6 Score on a Scale Standard Deviation 15.44	-3.7 Score on a Scale Standard Deviation 15.99	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline up to week 24

Population: Full analysis set with evaluable UCSD-SOBQ measures in IPF Cohort

The UCSD-SOBQ is a 24-item dyspnea questionnaire that asks participants to rate themselves from 0 ("Not at all") to 5 ("Maximally or unable to do because of breathlessness") in two areas: 1) how short of breath they are while performing various activities (21 items); and 2) how much shortness of breath, fear of hurting themselves by overexerting, and fear of shortness of breath limit them in their daily lives (3 items). If the subject does not routinely perform the activity, they are asked to estimate the degree of shortness of breath anticipated. The UCSD-SOBQ is scored by summing responses across all 24 items to form a total score. Scores range from 0 to 120. The lower the score the better.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=26 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=23 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=27 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Mean Change From Baseline in The University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ)	1.1 Score on a Scale Standard Deviation 17.28	-3.3 Score on a Scale Standard Deviation 16.69	-1.4 Score on a Scale Standard Deviation 16.19	—	—	—	—

SECONDARY outcome

Timeframe: From re-randomization to end of treatment (approximately 84 weeks)

Population: Re-randomized safety set

Number of participants with Adverse events at the end of the active treatment phase

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=31 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=27 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=15 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With Adverse Events at the End of the Active Treatment Phase TEAE	25 Participants	23 Participants	11 Participants	13 Participants	11 Participants	2 Participants	3 Participants
Number of Participants With Adverse Events at the End of the Active Treatment Phase TEAE related to study treatment	7 Participants	13 Participants	2 Participants	8 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events at the End of the Active Treatment Phase Serious TEAE	10 Participants	6 Participants	3 Participants	4 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events at the End of the Active Treatment Phase Serious TEAE related to study Drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events at the End of the Active Treatment Phase Severe TEAE	8 Participants	7 Participants	2 Participants	4 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events at the End of the Active Treatment Phase TEAE leading to Death	5 Participants	4 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events at the End of the Active Treatment Phase TEA leading to study treatment interruption	2 Participants	6 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events at the End of the Active Treatment Phase TEAE leading to permanent study treatment discontinuation	6 Participants	4 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

Population: Safety Set

Number of participants with Adverse events

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=8 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With Adverse Events in the Placebo Controlled Period TEAE	30 Participants	34 Participants	31 Participants	8 Participants	5 Participants	—	—
Number of Participants With Adverse Events in the Placebo Controlled Period TEAE related to study treatment	14 Participants	21 Participants	14 Participants	3 Participants	1 Participants	—	—
Number of Participants With Adverse Events in the Placebo Controlled Period Serious TEAE	6 Participants	4 Participants	2 Participants	1 Participants	0 Participants	—	—
Number of Participants With Adverse Events in the Placebo Controlled Period Serious TEAE related to study Drug	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Adverse Events in the Placebo Controlled Period Severe TEAE	4 Participants	8 Participants	3 Participants	0 Participants	0 Participants	—	—
Number of Participants With Adverse Events in the Placebo Controlled Period TEAE leading to Death	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	—	—
Number of Participants With Adverse Events in the Placebo Controlled Period TEA leading to study treatment interruption	6 Participants	3 Participants	5 Participants	0 Participants	2 Participants	—	—
Number of Participants With Adverse Events in the Placebo Controlled Period TEAE leading to permanent study treatment discontinuation	5 Participants	7 Participants	2 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From re-randomization to end of treatment (approximately 84 weeks)

Population: Re-randomized safety set

Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=31 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=27 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=15 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Basophils - Normal to low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Basophils - Normal to high	5 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Hemoglobin - Normal to low	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Hemoglobin - Normal to high	3 Participants	4 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Lymphocytes - Normal to low	2 Participants	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Lymphocytes - Normal to high	3 Participants	5 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Neutrophils - Normal to low	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Neutrophils - Normal to high	14 Participants	11 Participants	6 Participants	6 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Platelets - Normal to low	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the Active Treatment Extension Period Platelets - Normal to high	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

Population: Safety Set

Number of participants with worst changes in hematology laboratory parameters including: basophils, hemoglobin, lymphocytes, neutrophils and platelets.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=8 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Basophils - Normal to low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Basophils - Normal to high	3 Participants	0 Participants	1 Participants	3 Participants	2 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Hemoglobin - Normal to low	4 Participants	2 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Hemoglobin - Normal to high	2 Participants	2 Participants	3 Participants	0 Participants	0 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Lymphocytes - Normal to low	1 Participants	2 Participants	2 Participants	3 Participants	0 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Lymphocytes - Normal to high	4 Participants	4 Participants	2 Participants	3 Participants	1 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Neutrophils - Normal to low	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Neutrophils - Normal to high	6 Participants	10 Participants	7 Participants	3 Participants	2 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Platelets - Normal to low	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	—	—
Number of Participants With Worst Changes in Hematology Laboratory Parameters During the in the Placebo Controlled Period Platelets - Normal to high	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From re-randomization to end of treatment (approximately 84 weeks)

Population: Re-Randomized Safety Set

Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=31 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=27 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=15 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period Erythrocytes - Normal to abnormal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Active Treatment Extension Period Leukocytes - Normal to abnormal	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

Population: Safety Set

Number of participants who had a change from worst post- baseline in urinalysis laboratory analysis for the following measures: Erythrocytes, Leukocytes, Tubular Epithelial Cells

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=8 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period Erythrocytes - Normal to Abnormal	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With a Change From Worst Post-baseline in Urinalysis Laboratory Analysis in the Placebo Controlled Period Leukocytes - Normal to Abnormal	4 Participants	1 Participants	2 Participants	2 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)

Population: Re-Randomized Safety Set

Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=31 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=27 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=15 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period QT Interval	-14.3 msec Standard Deviation 29.70	0.2 msec Standard Deviation 23.85	-7.7 msec Standard Deviation 22.23	-10.9 msec Standard Deviation 22.53	-3.0 msec Standard Deviation 21.29	9.0 msec Standard Deviation 28.28	25.0 msec Standard Deviation 26.87
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period QTcF Interval	-3.9 msec Standard Deviation 21.13	2.2 msec Standard Deviation 18.75	-3.4 msec Standard Deviation 15.02	-1.9 msec Standard Deviation 4.94	5.6 msec Standard Deviation 26.09	14.0 msec Standard Deviation 11.31	23.5 msec Standard Deviation 4.95
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period QTcB Interval	1.3 msec Standard Deviation 21.06	3.5 msec Standard Deviation 25.53	-0.7 msec Standard Deviation 19.04	2.9 msec Standard Deviation 13.46	10.0 msec Standard Deviation 37.36	17.5 msec Standard Deviation 31.82	22.5 msec Standard Deviation 6.36
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period PR Interval	-9.2 msec Standard Deviation 17.07	9.2 msec Standard Deviation 18.63	-12.8 msec Standard Deviation 6.55	3.3 msec Standard Deviation 15.27	0.6 msec Standard Deviation 16.27	14.5 msec Standard Deviation 28.99	2.0 msec Standard Deviation 7.07
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period QRS Duration	-1.8 msec Standard Deviation 7.11	5.1 msec Standard Deviation 14.46	1.0 msec Standard Deviation 7.25	-3.8 msec Standard Deviation 5.60	2.1 msec Standard Deviation 7.24	2.5 msec Standard Deviation 2.12	14.5 msec Standard Deviation 13.44
Mean Change From Baseline in Electrocardiogram Measurements in the Active Treatment Extension Period RR Interval	-75.4 msec Standard Deviation 129.46	-14.0 msec Standard Deviation 148.45	-25.7 msec Standard Deviation 136.36	-77.9 msec Standard Deviation 181.66	-51.4 msec Standard Deviation 167.76	-28.0 msec Standard Deviation 272.94	15.5 msec Standard Deviation 135.06

SECONDARY outcome

Timeframe: from baseline to week 24

Population: Safety Set

Mean change from baseline in Electrocardiogram readings for the following measures: QT interval, QTcF interval, QTcB interval, PR interval, QRS duration and RR interval

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=8 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period QT Interval	-2.9 msec Standard Deviation 22.37	0.2 msec Standard Deviation 22.76	-1.8 msec Standard Deviation 26.23	-9.6 msec Standard Deviation 30.52	-15.0 msec Standard Deviation 15.56	—	—
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period QTcF Interval	-0.3 msec Standard Deviation 15.12	-0.9 msec Standard Deviation 13.23	-2.2 msec Standard Deviation 16.80	1.5 msec Standard Deviation 16.83	6.0 msec Standard Deviation 1.41	—	—
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period QTcB Interval	0.5 msec Standard Deviation 19.57	-1.2 msec Standard Deviation 16.57	-2.4 msec Standard Deviation 18.20	7.6 msec Standard Deviation 23.51	19.0 msec Standard Deviation 11.31	—	—
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period PR Interval	-5.1 msec Standard Deviation 13.89	-0.3 msec Standard Deviation 10.84	-0.8 msec Standard Deviation 12.02	-5.3 msec Standard Deviation 12.23	20.5 msec Standard Deviation 20.51	—	—
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period QRS Duration	2.0 msec Standard Deviation 8.86	2.1 msec Standard Deviation 9.65	-0.5 msec Standard Deviation 8.44	-0.9 msec Standard Deviation 6.74	-3.0 msec Standard Deviation 4.24	—	—
Mean Change From Baseline in Electrocardiogram Measurements in the Placebo Controlled Period RR Interval	-20.9 msec Standard Deviation 127.25	6.5 msec Standard Deviation 127.19	13.0 msec Standard Deviation 129.92	-68.4 msec Standard Deviation 173.55	-110.5 msec Standard Deviation 78.49	—	—

SECONDARY outcome

Timeframe: From re-randomization to 4 week follow up after end of treatment (approximately 84 weeks)

Population: Re-Randomized Safety Set

Number of participants with worst increase from baseline in systolic and diastolic blood pressure.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=31 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=27 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=15 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) n=15 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) n=3 Participants Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period systolic increase from baseline > 10 but ≤ 15 (mild)	5 Participants	4 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period systolic increase from baseline > 15 but ≤ 20 (moderate)	1 Participants	4 Participants	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period systolic increase from baseline > 20 (severe)	4 Participants	8 Participants	4 Participants	4 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period diastolic increase from baseline > 5 but ≤ 10 (mild)	6 Participants	6 Participants	7 Participants	3 Participants	4 Participants	1 Participants	2 Participants
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period diastolic increase from baseline > 10 but ≤ 15 (moderate)	5 Participants	3 Participants	2 Participants	4 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Active Extension Period diastolic increase from baseline > 15 (severe)	5 Participants	6 Participants	5 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from baseline to re-randomization (approximately 56 weeks for the IPF cohort and 28 weeks for the PPF cohort)

Population: Safety Set

Number of participants with worst increase from baseline in systolic and diastolic blood pressure.

Outcome measures

Outcome measures
Measure	CC-90001 200mg (IPF Study) n=39 Participants CC-90001 200mg PO QD	CC-90001 400mg (IPF Study) n=37 Participants CC-90001 400mg PO QD	Placebo (IPF Study) n=36 Participants Placebo	Placebo/CC-90001 200mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (IPF Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase	Placebo/CC-90001 200mg (PPF Sub-study) Participants who received placebo in the placebo treatment phase and then CC-90001 200mg PO QD in the active treatment extension phase	Placebo/CC-90001 400mg (PPF Sub-Study) Participants who received placebo in the placebo treatment phase and then CC-90001 400mg PO QD in the active treatment extension phase
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period systolic increase from baseline > 10 but ≤ 15 (mild)	2 Participants	0 Participants	2 Participants	—	—	—	—
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period systolic increase from baseline > 15 but ≤ 20 (moderate)	3 Participants	2 Participants	3 Participants	—	—	—	—
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period systolic increase from baseline > 20 (severe)	0 Participants	3 Participants	0 Participants	—	—	—	—
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period diastolic increase from baseline > 5 but ≤ 10 (mild)	4 Participants	2 Participants	1 Participants	—	—	—	—
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period diastolic increase from baseline > 10 but ≤ 15 (moderate)	3 Participants	2 Participants	1 Participants	—	—	—	—
Number of Participants With Worst Increase From Baseline in Blood Pressure in the Placebo-controlled Period diastolic increase from baseline > 15 (severe)	2 Participants	2 Participants	2 Participants	—	—	—	—

Adverse Events

CC-90001 200mg IPF Study

Serious events: 16 serious events

Other events: 32 other events

Deaths: 5 deaths

CC-90001 400mg IPF Study

Serious events: 9 serious events

Other events: 33 other events

Deaths: 5 deaths

Placebo IPF Study

Serious events: 2 serious events

Other events: 31 other events

Deaths: 2 deaths

Active Treatment Phase CC-90001 200mg Following Placebo IPF Study

Serious events: 3 serious events

Other events: 10 other events

Deaths: 2 deaths

Active Treatment Phase CC-90001 400mg Following Placebo IPF Study

Serious events: 4 serious events

Other events: 13 other events

Deaths: 2 deaths

CC-90001 400mg PPF Sub-Study

Serious events: 3 serious events

Other events: 12 other events

Deaths: 1 deaths

Placebo PPF Sub-Study

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Active Treatment Phase CC-90001 200mg Following Placebo PPF Sub-Study

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Active Treatment Phase CC-90001 400mg Following Placebo PPF Sub-Study

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CC-90001 200mg IPF Study n=39 participants at risk CC-90001 200mg PO QD	CC-90001 400mg IPF Study n=37 participants at risk CC-90001 400mg PO QD	Placebo IPF Study n=36 participants at risk Placebo	Active Treatment Phase CC-90001 200mg Following Placebo IPF Study n=15 participants at risk CC-90001 200mg PO QD	Active Treatment Phase CC-90001 400mg Following Placebo IPF Study n=15 participants at risk CC-90001 400mg PO QD	CC-90001 400mg PPF Sub-Study n=15 participants at risk CC-90001 400mg PO QD	Placebo PPF Sub-Study n=8 participants at risk Placebo	Active Treatment Phase CC-90001 200mg Following Placebo PPF Sub-Study n=3 participants at risk CC-90001 200mg PO QD	Active Treatment Phase CC-90001 400mg Following Placebo PPF Sub-Study n=3 participants at risk CC-90001 400mg PO QD
Blood and lymphatic system disorders Neutropenia	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Acute coronary syndrome	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Acute myocardial infarction	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Angina pectoris	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Obstructive pancreatitis	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Pancreatitis acute	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Multiple organ dysfunction syndrome	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Non-cardiac chest pain	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Drug-induced liver injury	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Atypical pneumonia	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bronchitis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19 pneumonia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Diverticulitis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Haemophilus infection	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Lower respiratory tract infection	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia aspiration	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia bacterial	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Suspected COVID-19	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Troponin increased	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebrovascular accident	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Post herpetic neuralgia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Other adverse events
Measure	CC-90001 200mg IPF Study n=39 participants at risk CC-90001 200mg PO QD	CC-90001 400mg IPF Study n=37 participants at risk CC-90001 400mg PO QD	Placebo IPF Study n=36 participants at risk Placebo	Active Treatment Phase CC-90001 200mg Following Placebo IPF Study n=15 participants at risk CC-90001 200mg PO QD	Active Treatment Phase CC-90001 400mg Following Placebo IPF Study n=15 participants at risk CC-90001 400mg PO QD	CC-90001 400mg PPF Sub-Study n=15 participants at risk CC-90001 400mg PO QD	Placebo PPF Sub-Study n=8 participants at risk Placebo	Active Treatment Phase CC-90001 200mg Following Placebo PPF Sub-Study n=3 participants at risk CC-90001 200mg PO QD	Active Treatment Phase CC-90001 400mg Following Placebo PPF Sub-Study n=3 participants at risk CC-90001 400mg PO QD
Blood and lymphatic system disorders Neutrophilia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial fibrillation	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial flutter	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders Vertigo	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Cataract	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal discomfort	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal distension	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	25.6% 10/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	29.7% 11/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.0% 3/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	26.7% 4/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dyspepsia	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Flatulence	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	30.8% 12/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	43.2% 16/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.1% 4/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	40.0% 6/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	26.7% 4/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Toothache	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	15.4% 6/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	18.9% 7/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bronchitis	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.0% 3/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cystitis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Herpes zoster	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Influenza	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Lower respiratory tract infection	10.3% 4/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.1% 4/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pain	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Nasopharyngitis	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.5% 5/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pyelonephritis acute	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pyelonephritis chronic	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Respiratory tract infection	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Rhinitis	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sialoadenitis	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sinusitis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	12.8% 5/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.8% 4/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	10.3% 4/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Vulvovaginal candidiasis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Contusion	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fall	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Limb injury	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Rib fracture	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Skin laceration	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood glucose increased	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood lactate dehydrogenase increased	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood pressure increased	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood triglycerides increased	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Gamma-glutamyltransferase increased	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Low density lipoprotein decreased	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Neutrophil count increased	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Oxygen saturation decreased	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight decreased	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Decreased appetite	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	26.7% 4/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Gout	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Vitamin D deficiency	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.5% 5/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Muscle spasms	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.8% 4/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Neck pain	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.8% 4/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.2% 6/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dysgeusia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	18.9% 7/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.0% 3/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Paraesthesia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Anxiety	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Depression	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Insomnia	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Dysuria	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Pollakiuria	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Renal cyst	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Renal pain	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Cough	30.8% 12/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	18.9% 7/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	30.6% 11/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.9% 7/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.2% 6/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.1% 4/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.0% 3/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	7.7% 3/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Productive cough	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	5.1% 2/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.1% 3/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Social circumstances Dependence on oxygen therapy	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 2/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 2/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrioventricular block first degree	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastric polyps	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastric ulcer	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Haemorrhoids	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Melaena	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Varices oesophageal	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Chest pain	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Feeling abnormal	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Malaise	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Labyrinthitis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Oral herpes	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Respiratory tract infection bacterial	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Tooth infection	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Urine cytology abnormal	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight increased	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypocholesterolaemia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Ageusia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hypoaesthesia	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.7% 1/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Sputum increased	2.6% 1/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/39 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/37 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.7% 1/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/15 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 84 weeks All-Cause mortality (From randomization to end of study): Approximately 104 weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60