Trial Outcomes & Findings for Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia. (NCT NCT01571635)

NCT ID: NCT01571635

Last Updated: 2023-06-18

Results Overview

Number of participants with dose-limiting toxicities (DLT) are used to determine the potential recommended dose (PRD). PRD is defined as the highest dose with up to 1 out of 6 patients experiencing a DLT. DLT is defined as any side effects of the study treatment serious enough to prevent an increase in dose or level of treatment, including at least one of the following: Hypertension ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Hgb \> 14 g/dL sustained for four weeks; any NCI CTCAE toxicity ≥ Grade 3. Grade 3 is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily life. PRD was identified as 1 mg/kg. Due to study termination, no patients were enrolled after 1 mg/kg cohort or in the Expansion Cohort. Thus, primary analyses to determine recommended dose (RD) were not conducted.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: From first dose up to 28 days post the first dose
• Results posted on: 2023-06-18

Participant Flow

The Sponsor decided to stop advancing sotatercept development in the β-thalassemia indication; therefore, the study participants enrollment stopped during the Treatment Period. No participants were enrolled in the dose level 1.5 mg/kg that was planned in the protocol. Additionally, the protocol planned to enroll approximately 30 participants in an expansion cohort once the potential recommended dose (PRD) was defined. Due to early termination of the study, the expansion cohort was not opened.

Participant milestones

Measure	Dose Level 1a: 0.1 mg/kg Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Overall Study STARTED	8	9	8	12	9
Overall Study COMPLETED	2	1	1	0	0
Overall Study NOT COMPLETED	6	8	7	12	9

Reasons for withdrawal

Measure	Dose Level 1a: 0.1 mg/kg Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Overall Study Adverse Event	3	0	2	3	5
Overall Study Other reasons	2	1	2	2	1
Overall Study Study terminated by sponsor	0	4	1	3	1
Overall Study Withdrew consent	1	1	2	3	0
Overall Study Lack of Efficacy	0	2	0	1	2

Baseline Characteristics

Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia.

Baseline characteristics by cohort

Measure	Dose Level 1a: 0.1 mg/kg n=8 Participants Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=9 Participants Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=8 Participants Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=12 Participants Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=9 Participants Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Total n=46 Participants Total of all reporting groups
Age, Continuous	39.5 Years STANDARD_DEVIATION 8.21 • n=5 Participants	40.0 Years STANDARD_DEVIATION 9.89 • n=7 Participants	38.5 Years STANDARD_DEVIATION 7.63 • n=5 Participants	44.0 Years STANDARD_DEVIATION 10.29 • n=4 Participants	41.0 Years STANDARD_DEVIATION 10.36 • n=21 Participants	39.5 Years STANDARD_DEVIATION 9.22 • n=10 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	22 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	24 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	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	4 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	7 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	8 Participants n=21 Participants	40 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	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: From first dose up to 28 days post the first dose

Population: All treated participants

Number of participants with dose-limiting toxicities (DLT) are used to determine the potential recommended dose (PRD). PRD is defined as the highest dose with up to 1 out of 6 patients experiencing a DLT. DLT is defined as any side effects of the study treatment serious enough to prevent an increase in dose or level of treatment, including at least one of the following: Hypertension ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Hgb > 14 g/dL sustained for four weeks; any NCI CTCAE toxicity ≥ Grade 3. Grade 3 is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily life.

PRD was identified as 1 mg/kg. Due to study termination, no patients were enrolled after 1 mg/kg cohort or in the Expansion Cohort. Thus, primary analyses to determine recommended dose (RD) were not conducted.

Outcome measures

Measure	Dose Level 1a: 0.1 mg/kg n=8 Participants Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=9 Participants Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=8 Participants Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=12 Participants Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=9 Participants Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Potential Recommended Dose as Determined by Number of Participants Experiencing Dose-Limiting Toxicities and Recommended Dose	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to the last dose of study treatment (up to approximately 112 months)

Population: Safety Population Transfusion Dependent-All participants who received at least one dose of sotatercept and are transfusion dependent.

Transfusion burden at baseline is defined as the total number of units of RBC transfusions that participants received within 168 days (24 weeks) prior to the first dose of study therapy. Transfusion burden during treatment is defined as the total number of RBC transfusion units that each participant received during the treatment divided by the treatment duration and multiplied by 168 days. The result is a 168-day transfusion burden average. Baseline measurement includes RBC transfusion history for transfusion dependent and non-transfusion dependent participants, starting at 168 days prior to enrollment.

Outcome measures

Measure	Dose Level 1a: 0.1 mg/kg n=2 Participants Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=3 Participants Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=2 Participants Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=5 Participants Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=4 Participants Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Number of Participants With Red Blood Cell Transfusion Burden Reduction From Baseline During Treatment ≥ 25% reduction	0 Participants	0 Participants	2 Participants	4 Participants	3 Participants
Number of Participants With Red Blood Cell Transfusion Burden Reduction From Baseline During Treatment ≥ 33% reduction	0 Participants	0 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Red Blood Cell Transfusion Burden Reduction From Baseline During Treatment ≥ 50% reduction	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Measurements were taken in 9 and 12-week intervals, from baseline up to approximately 112 months

Population: Non-RBC transfusion dependent participants-participants who are in the safety population and are not transfusion dependent. This is a subgroup of the B-thalassemia intermedia population.

The Number of participants with a change in Hemoglobin levels will be listed for non-RBC transfusion dependent participants. Baseline assessments are the average of the last two measurements prior to the start of therapy.

Outcome measures

Measure	Dose Level 1a: 0.1 mg/kg n=6 Participants Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=6 Participants Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=6 Participants Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=7 Participants Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=5 Participants Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Number of Participants With Hemoglobin Level Increase From Baseline in Non-Transfusion Dependent B-Thalassemia Intermedia Participants 12-Week episode with Hgb ≥ 1.5 g/dl change from baseline (non-transfusion dependent participants)	0 Participants	2 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Hemoglobin Level Increase From Baseline in Non-Transfusion Dependent B-Thalassemia Intermedia Participants 9-week episode with Hgb ≥ 1.0 g/dl change from baseline (non-transfusion dependent participants)	0 Participants	5 Participants	4 Participants	6 Participants	2 Participants
Number of Participants With Hemoglobin Level Increase From Baseline in Non-Transfusion Dependent B-Thalassemia Intermedia Participants 9-week episode with Hgb ≥ 1.5 g/dl change from baseline (non-transfusion dependent participants)	0 Participants	2 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Hemoglobin Level Increase From Baseline in Non-Transfusion Dependent B-Thalassemia Intermedia Participants 12-Week episode with Hgb ≥ 1.0 g/dl change from baseline (non-transfusion dependent participants)	0 Participants	4 Participants	4 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose up to 112 days after the last dose of study treatment (up to 115 months)

Population: All treated participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. Treatment emergent adverse events (TEAE) are defined as an AE that began after the start of trial medication treatment; or if the event was continuous from baseline and was serious, trial medication-related, or resulted in death, discontinuation, or interruption or reduction of trial therapy.

Outcome measures

Measure	Dose Level 1a: 0.1 mg/kg n=8 Participants Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=9 Participants Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=8 Participants Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=12 Participants Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=9 Participants Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Number of Participants Experiencing Adverse Events (AEs) TEAE leading to dose interruption	2 Participants	5 Participants	4 Participants	2 Participants	5 Participants
Number of Participants Experiencing Adverse Events (AEs) Participants with at least one TEAE leading to sotatercept withdrawal	3 Participants	0 Participants	2 Participants	3 Participants	5 Participants
Number of Participants Experiencing Adverse Events (AEs) Participants with at least one TEAE	8 Participants	9 Participants	8 Participants	12 Participants	9 Participants
Number of Participants Experiencing Adverse Events (AEs) Participants with at least one serious TEAE	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants
Number of Participants Experiencing Adverse Events (AEs) Participants with at least one grade 2/3/4 TEAE	7 Participants	9 Participants	6 Participants	11 Participants	9 Participants
Number of Participants Experiencing Adverse Events (AEs) Participants with at least one drug-related grade 2/3/4 TEAE	4 Participants	3 Participants	4 Participants	7 Participants	7 Participants
Number of Participants Experiencing Adverse Events (AEs) Participants with at least one serious drug- related TEAE	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Dose 1, Day 8; Dose 1, Day 15; Dose 2, Day 1; Dose 2, Day 8; Dose 3, Day 1; Dose 3, Day 8; Dose 4, Day 1; Dose 5, Day 1; Dose 6, Day 1

Population: All treated participants

Sotatercept was administered as a subcutaneous injection every 21 days during the Treatment Period. Pharmacokinetic (PK) samples were collected at the pre-specified timepoints.

Outcome measures

Measure	Dose Level 1a: 0.1 mg/kg n=8 Participants Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=9 Participants Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=8 Participants Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=12 Participants Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=9 Participants Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Concentrations of Sotatercept in Serum Dose 1, Day 8	598.3 ng/mL Interval 289.2 to 1345.4	1454.05 ng/mL Interval 1006.6 to 2768.3	3045.45 ng/mL Interval 1586.7 to 4480.0	5837.65 ng/mL Interval 3238.1 to 10590.5	3874 ng/mL Interval 2264.9 to 7003.0
Concentrations of Sotatercept in Serum Dose 1, Day 15	388.7 ng/mL Interval 98.4 to 1046.0	1150.1 ng/mL Interval 550.3 to 2158.4	2329.75 ng/mL Interval 952.0 to 3005.5	4279.65 ng/mL Interval 2107.8 to 6692.0	2405.6 ng/mL Interval 1825.3 to 4605.5
Concentrations of Sotatercept in Serum Dose 2, Day 1	294.75 ng/mL Interval 112.9 to 547.1	770.3 ng/mL Interval 317.2 to 1300.1	1468.05 ng/mL Interval 682.0 to 2550.5	2955.2 ng/mL Interval 1257.5 to 4450.8	1701.5 ng/mL Interval 888.6 to 4267.9
Concentrations of Sotatercept in Serum Dose 2, Day 8	683.1 ng/mL Interval 250.1 to 1210.6	2065 ng/mL Interval 1363.7 to 3626.4	4136.8 ng/mL Interval 1661.9 to 5573.8	7753.35 ng/mL Interval 5046.4 to 8805.6	5148.1 ng/mL Interval 3537.4 to 10418.7
Concentrations of Sotatercept in Serum Dose 3, Day 1	325.35 ng/mL Interval 228.8 to 790.0	956.8 ng/mL Interval 380.6 to 1552.6	2157.3 ng/mL Interval 422.0 to 3088.4	3628.45 ng/mL Interval 653.5 to 6429.1	2602.6 ng/mL Interval 822.2 to 5668.1
Concentrations of Sotatercept in Serum Dose 3, Day 8	758.1 ng/mL Interval 444.0 to 1232.0	2319.9 ng/mL Interval 1475.6 to 3667.4	4507.3 ng/mL Interval 2077.8 to 5762.3	8373.05 ng/mL Interval 5345.5 to 12177.8	6050.8 ng/mL Interval 3892.5 to 12139.6
Concentrations of Sotatercept in Serum Dose 4, Day 1	334.85 ng/mL Interval 298.0 to 1014.9	1022.3 ng/mL Interval 348.8 to 2096.9	2441.6 ng/mL Interval 784.0 to 2845.3	4137.1 ng/mL Interval 1447.1 to 6126.6	2869.2 ng/mL Interval 1478.9 to 4787.7
Concentrations of Sotatercept in Serum Dose 5, Day 1	385.1 ng/mL Interval 287.5 to 467.5	1473.9 ng/mL Interval 762.1 to 2764.4	1618.8 ng/mL Interval 953.4 to 3440.0	4449.7 ng/mL Interval 2340.4 to 5887.8	3048 ng/mL Interval 1125.5 to 6529.3
Concentrations of Sotatercept in Serum Dose 6, Day 1	297.60 ng/mL Interval 227.8 to 484.4	1368.10 ng/mL Interval 449.7 to 2363.2	2266.40 ng/mL Interval 1115.2 to 3788.5	4062.80 ng/mL Interval 1481.1 to 6584.0	2780.80 ng/mL Interval 1479.2 to 7896.7

SECONDARY outcome

Timeframe: From first dose up to 4 months after last dose (up to approximately 116 months)

Population: All treated participants

The number of participants with Anti-Sotatercept Antibody is a summary of antidrug antibody (ADA) status for ADA-evaluated participants. A participant is counted as 'positive' if there is any positive result captured during the study, a participant is counted as 'negative' if there is no positive result captured during the study. ADA data was collected Day 1 in dose schedules 1 through 6. Starting from Dose 7, ADA was measured at Day 1 every 3 Doses, then finally at the post-treatment follow-up visit at Month 2 and Month 4.

Outcome measures

Measure	Dose Level 1a: 0.1 mg/kg n=8 Participants Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=9 Participants Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=8 Participants Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=12 Participants Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=9 Participants Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Number of Participants With Anti-Drug Antibody (ADA) Negative	8 Participants	8 Participants	8 Participants	10 Participants	9 Participants
Number of Participants With Anti-Drug Antibody (ADA) Positive	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From pre-dose up to Dose 8 (168 days/6months) and Dose 16 (336 days/12months) only

Population: Expansion cohort

The number of participants in the expansion cohort experiencing changes from baseline in Quality of Life. QOL was planned to be assessed at Day 168 (6 months) and Day 336 (12 months), after Dose 1 Day 1, independent of Dose Delay for participants enrolled in the Expansion Cohort only. QOL was planned to be calculated using the SF-36 and the FACT Anemia. The SF-36 is a Medical Outcomes Study (MOS) consisting of 36 questions developed to determine health status. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The FACT Anemia measures fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) Measurement System.

Due to early study termination, no participants were enrolled in the expansion cohort and QOL was not assessed.

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 1a: 0.1 mg/kg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Dose Level 1b: 0.3 mg/kg

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Dose Level 2: 0.5 mg/kg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Dose Level 3: 0.75 mg/kg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Dose Level 4: 1 mg/kg

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Level 1a: 0.1 mg/kg n=8 participants at risk Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=9 participants at risk Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=8 participants at risk Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=12 participants at risk Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=9 participants at risk Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders EXTRAMEDULLARY HAEMOPOIESIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders SPLENIC INFARCTION	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders SUBILEUS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders FATIGUE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders LOCAL SWELLING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders PYREXIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Immune system disorders ANAPHYLACTIC REACTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations BACTERIAL PROSTATITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations CORONA VIRUS INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations PHARYNGOTONSILLITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications FALL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications FOREARM FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications PELVIC FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications PUBIS FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications ULNA FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders BONE PAIN	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders SPINAL CORD COMPRESSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders SYNCOPE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders THROMBOPHLEBITIS SUPERFICIAL	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders THROMBOSIS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)

Other adverse events

Measure	Dose Level 1a: 0.1 mg/kg n=8 participants at risk Dose level 1a (starting dose) 0.1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 1b: 0.3 mg/kg n=9 participants at risk Dose level 1b (starting dose) 0.3 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 2: 0.5 mg/kg n=8 participants at risk Dose level 2 (escalation dose) 0.5 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 3: 0.75 mg/kg n=12 participants at risk Dose level 3 (escalation dose) 0.75 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.	Dose Level 4: 1 mg/kg n=9 participants at risk Dose level 4 (escalation dose) 1 mg/kg Sotatercept will be administered as an SC injection once every 21 days for up to six planned doses during the Treatment Period.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Social circumstances MENOPAUSE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders SENSATION OF HEAVINESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders SPONDYLOLISTHESIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders TEMPOROMANDIBULAR JOINT SYNDROME	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders TENDON PAIN	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders ANAEMIA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders BONE MARROW FAILURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders BONE MARROW OEDEMA SYNDROME	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders EXTRAMEDULLARY HAEMOPOIESIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders LYMPH NODE PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders SPLENOMEGALY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders EXTRASYSTOLES	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders LEFT ATRIAL DILATATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders PALPITATIONS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders SPLINTER HAEMORRHAGES	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders TACHYCARDIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Congenital, familial and genetic disorders BENIGN FAMILIAL HAEMATURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Ear and labyrinth disorders DEAFNESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Ear and labyrinth disorders EAR PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Ear and labyrinth disorders EXTERNAL EAR INFLAMMATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Ear and labyrinth disorders TINNITUS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Ear and labyrinth disorders VERTIGO	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Endocrine disorders AUTOIMMUNE THYROIDITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Endocrine disorders HYPERPROLACTINAEMIA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Endocrine disorders HYPERTHYROIDISM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Endocrine disorders THYROID CYST	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Endocrine disorders THYROIDITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders BLEPHARITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders CONJUNCTIVAL HAEMORRHAGE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders CONJUNCTIVITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders CONJUNCTIVITIS ALLERGIC	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders DACRYOSTENOSIS ACQUIRED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders EYE PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders EYE SWELLING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders LACRIMAL DISORDER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders LACRIMATION INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders OCULAR HYPERAEMIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders PINGUECULA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Eye disorders PTERYGIUM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ABDOMINAL PAIN	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ABDOMINAL PAIN LOWER	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ABDOMINAL PAIN UPPER	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	55.6% 5/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 4/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ANAL PRURITUS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders COLITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders CONSTIPATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders DENTAL CARIES	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders OEDEMA PERIPHERAL	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders DENTAL DISCOMFORT	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders DIARRHOEA	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders DUODENOGASTRIC REFLUX	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders DYSPEPSIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders FAECALOMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders FOOD POISONING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders GASTRITIS EROSIVE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders GASTRITIS HAEMORRHAGIC	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders GINGIVAL BLEEDING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders HAEMORRHOIDS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders HYPERCHLORHYDRIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders LIP DISCOLOURATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders NAUSEA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 3/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ODYNOPHAGIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders ORAL DISORDER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders PARAESTHESIA ORAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders PAROTID GLAND ENLARGEMENT	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders STOMATITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders TEETHING	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders TOOTHACHE	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Gastrointestinal disorders VOMITING	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders ASTHENIA	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	41.7% 5/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders CHEST DISCOMFORT	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders CHEST PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders CHILLS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders CYST	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders FATIGUE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders GENERALISED OEDEMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders GRANULOMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders INFLUENZA LIKE ILLNESS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders INJECTION SITE ERYTHEMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders INJECTION SITE INFLAMMATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders IRRITABILITY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders LOCAL SWELLING	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders LOCALISED OEDEMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders MALAISE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders MUCOSAL HYPERAEMIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders PYREXIA	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	66.7% 6/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 3/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders VACCINATION SITE ERYTHEMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders VACCINATION SITE LYMPHADENOPATHY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders VACCINATION SITE PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders VACCINATION SITE SWELLING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders VACCINATION SITE WARMTH	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
General disorders DEFICIT FOLATE	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Hepatobiliary disorders BILIARY DILATATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Hepatobiliary disorders CHOLESTASIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Hepatobiliary disorders GALLBLADDER POLYP	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Hepatobiliary disorders HEPATOCELLULAR INJURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Hepatobiliary disorders PORTAL HYPERTENSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Immune system disorders ALLERGY TO ARTHROPOD STING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Immune system disorders ALLOIMMUNISATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Immune system disorders ANAPHYLACTIC REACTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Immune system disorders HYPERSENSITIVITY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Immune system disorders SEASONAL ALLERGY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations ACNE PUSTULAR	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations ACUTE SINUSITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations ACUTE TONSILLITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations BODY TINEA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations BRONCHITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations CONJUNCTIVITIS VIRAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations CYSTITIS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations EAR INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations EYE INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations EYELID INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations FOLLICULITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations GASTROENTERITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations GINGIVAL INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations GINGIVITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations HELICOBACTER INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations HORDEOLUM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations INFECTED BITES	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations INFECTED SKIN ULCER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations INFLUENZA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	55.6% 5/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations KLEBSIELLA INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations NASOPHARYNGITIS	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations ONYCHOMYCOSIS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations ORAL HERPES	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations OTITIS EXTERNA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations PARAINFLUENZAE VIRUS INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations PARONYCHIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations PERIODONTITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations PHARYNGITIS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations PNEUMONIA VIRAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations RHINITIS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	62.5% 5/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations SINUSITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations TINEA PEDIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations TONSILLITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations TOOTH ABSCESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations TOOTH INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations TRACHEITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations TROPICAL ULCER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations URINARY TRACT INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations URINARY TRACT INFECTION BACTERIAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations URINARY TRACT INFECTION FUNGAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations VAGINAL INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations VIRAL INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations VULVOVAGINAL CANDIDIASIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Infections and infestations VULVOVAGINAL MYCOTIC INFECTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications ARTHROPOD STING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications CHEST INJURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications CONTUSION	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications EPICONDYLITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications FALL	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications FOOT FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications FRACTURED SACRUM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications HAEMOLYTIC TRANSFUSION REACTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications LACERATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications LIMB INJURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications MENISCUS INJURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications NAIL INJURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications OVERDOSE	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications PATELLA FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications POST-TRAUMATIC PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications REPETITIVE STRAIN INJURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications RIB FRACTURE	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications SOFT TISSUE INJURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications TENDON RUPTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications TOOTH INJURY	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications TRANSFUSION REACTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications VACCINATION COMPLICATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations ALANINE AMINOTRANSFERASE INCREASED	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations BLOOD CREATININE INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations BLOOD FOLATE DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations BLOOD FOLLICLE STIMULATING HORMONE DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations BLOOD PRESSURE INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations CARDIAC INDEX INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations CREATININE RENAL CLEARANCE DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations CULTURE STOOL POSITIVE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations EJECTION FRACTION DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations ELECTROCARDIOGRAM QT SHORTENED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations ELECTROCARDIOGRAM T WAVE ABNORMAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations ESCHERICHIA TEST POSITIVE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations FIBRIN D DIMER INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations GLOMERULAR FILTRATION RATE DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations HEPATIC ENZYME INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations PANCREATIC ENZYMES INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations PLATELET COUNT INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations SERUM FERRITIN INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations ULTRASOUND LIVER ABNORMAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations ULTRASOUND SCAN ABNORMAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations URINE PROTEIN/CREATININE RATIO INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations VITAMIN D DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations WEIGHT DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Investigations WEIGHT INCREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders DECREASED APPETITE	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders FOLATE DEFICIENCY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders GOUT	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders HYPERURICAEMIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders IRON OVERLOAD	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders ARTHRALGIA	62.5% 5/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	66.7% 6/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	87.5% 7/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	66.7% 8/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders BACK PAIN	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	77.8% 7/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	75.0% 6/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	41.7% 5/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders BONE DISORDER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders BONE PAIN	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	66.7% 6/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 4/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders COCCYDYNIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders FLANK PAIN	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders JOINT EFFUSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders JOINT STIFFNESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders JOINT SWELLING	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders LIGAMENT DISORDER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 3/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 4/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders MYALGIA	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders NECK PAIN	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	41.7% 5/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders OSTEOPENIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	62.5% 5/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	41.7% 5/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders PAIN IN JAW	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Musculoskeletal and connective tissue disorders TENDONITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA OF LIVER	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOCYTIC NAEVUS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NEOPLASM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders AGEUSIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders CERVICOBRACHIAL SYNDROME	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders DIZZINESS	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders DYSARTHRIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders DYSGEUSIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders FACIAL NEURALGIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders HEADACHE	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	66.7% 6/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	62.5% 5/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	75.0% 9/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders HYPERAESTHESIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders MIGRAINE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders PRESYNCOPE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders SCIATICA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders SINUS HEADACHE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders SOMNOLENCE	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders TREMOR	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Nervous system disorders VISUAL FIELD DEFECT	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Psychiatric disorders ANXIETY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Psychiatric disorders BRUXISM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Psychiatric disorders DEPRESSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Psychiatric disorders INSOMNIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Psychiatric disorders LIBIDO DECREASED	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Psychiatric disorders STRESS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders DYSURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders HAEMATURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders LEUKOCYTURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders MICROALBUMINURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders NEPHROPATHY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders POLLAKIURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders POLYURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders PROTEINURIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders RENAL COLIC	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders RENAL CYST	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders STRANGURY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Renal and urinary disorders URINARY RETENTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders AMENORRHOEA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders BREAST CYST	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders CYSTOCELE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders DYSMENORRHOEA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders EPIDIDYMITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders OLIGOMENORRHOEA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders PROSTATOMEGALY	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Reproductive system and breast disorders UTERINE PROLAPSE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders ALLERGIC RESPIRATORY DISEASE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders ASTHMATIC CRISIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders COUGH	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	62.5% 5/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 3/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders DYSPNOEA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders EPISTAXIS	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 4/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders LUNG CYST	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	44.4% 4/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	55.6% 5/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 4/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders PULMONARY MASS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT CONGESTION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders SNEEZING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Respiratory, thoracic and mediastinal disorders YAWNING	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders DERMAL CYST	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders DERMATITIS	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders ERYTHEMA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders HAIR TEXTURE ABNORMAL	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders HIRSUTISM	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders PAPULE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders PETECHIAE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	16.7% 2/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders PURPURA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders RASH	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders SEBORRHOEIC DERMATITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders SKIN DISCOLOURATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders SKIN HAEMORRHAGE	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders SKIN LESION	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders SKIN ULCER	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders SPIDER NAEVUS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Skin and subcutaneous tissue disorders URTICARIA	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders HAEMATOMA	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders HOT FLUSH	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders HYPERTENSION	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	33.3% 3/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	41.7% 5/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	22.2% 2/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders HYPOTENSION	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	11.1% 1/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders PREHYPERTENSION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	8.3% 1/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders THROMBOPHLEBITIS	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)
Vascular disorders VENOUS RECANALISATION	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/12 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)	0.00% 0/9 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 115 months). SAEs and Other AEs were assessed from first dose to 112 days following last dose (up to approximately 115 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER