Trial Outcomes & Findings for Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis (NCT NCT03824392)

NCT ID: NCT03824392

Last Updated: 2023-07-18

Results Overview

An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs were defined as any adverse event or worsening of an existing condition after initiation of the investigational product and through 30 days after the participant's last study visit (study completion or early termination). SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: Baseline up to Week 24
• Results posted on: 2023-07-18

Participant Flow

Participant milestones

Measure	Placebo Participants received placebo matched to efzofitimod via intravenous (IV) infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg Participants received efzofitimod 1.0 milligrams/kilogram (mg/kg) via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Overall Study STARTED	12	8	8	9
Overall Study Received at Least 1 Dose of Study Drug	12	8	8	9
Overall Study COMPLETED	9	6	5	8
Overall Study NOT COMPLETED	3	2	3	1

Reasons for withdrawal

Measure	Placebo Participants received placebo matched to efzofitimod via intravenous (IV) infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg Participants received efzofitimod 1.0 milligrams/kilogram (mg/kg) via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Overall Study Adverse Event	1	0	0	0
Overall Study Investigator Decision	0	1	0	0
Overall Study Participant Unable to Participate Due to COVID-19 Quarantine Restrictions	2	1	3	1

Baseline Characteristics

Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis

Baseline characteristics by cohort

Measure	Placebo n=12 Participants Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 Participants Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 Participants Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 Participants Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.	Total n=37 Participants Total of all reporting groups
Age, Continuous	52.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	54.5 years STANDARD_DEVIATION 11.3 • n=7 Participants	51.8 years STANDARD_DEVIATION 11.4 • n=5 Participants	50.8 years STANDARD_DEVIATION 9.2 • n=4 Participants	52.4 years STANDARD_DEVIATION 10.1 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	17 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	35 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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
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
Race (NIH/OMB) Asian	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
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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	23 Participants n=21 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
Race (NIH/OMB) Unknown or Not Reported	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

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.

An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs were defined as any adverse event or worsening of an existing condition after initiation of the investigational product and through 30 days after the participant's last study visit (study completion or early termination). SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

Outcome measures

Measure	Placebo n=12 Participants Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 Participants Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 Participants Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 Participants Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	10 Participants	8 Participants	7 Participants	8 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24 (Day 1 to End of Dosing Period)

Population: The modified intent-to-treat (mITT) Set included all participants who had received any amount of study drug and were based on the randomized treatment, regardless of which treatment the participant actually received.

Time adjusted AUC is a measure of steroid burden and approximates the average daily OCS dose (mg/day) post-baseline for each participant. Time adjusted AUC was calculated by AUC divided by the number of days between first and last day of time interval of interest.

Outcome measures

Measure	Placebo n=12 Participants Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 Participants Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 Participants Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 Participants Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Time-adjusted Area Under the Curve (AUC) of Background Oral Corticosteroid (OCS) Usage Over Study Period	8.64 mg/day Standard Deviation 4.20	6.83 mg/day Standard Deviation 1.41	8.36 mg/day Standard Deviation 3.68	7.43 mg/day Standard Deviation 3.30

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: The mITT Set included all participants who had received any amount of study drug and were based on the randomized treatment, regardless of which treatment the participant actually received.

Outcome measures

Measure	Placebo n=12 Participants Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 Participants Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 Participants Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 Participants Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Number of Participants Who Achieved and Maintained The Targeted Tapered Dose of Prednisone 5 mg/Day (or Equivalent)	7 Participants	1 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: The mITT Set included all participants who had received any amount of study drug and were based on the randomized treatment, regardless of which treatment the participant actually received.

The number of all participants having drug reactive antibodies at any point in time (efzofitimod and placebo matched to efzofitimod) have been reported.

Outcome measures

Measure	Placebo n=12 Participants Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 Participants Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 Participants Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 Participants Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Number of Participants With Positive Anti-Drug Antibodies (Anti-Efzofitimod)	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: The mITT Set included all participants who had received any amount of study drug and were based on the randomized treatment, regardless of which treatment the participant actually received.

Outcome measures

Measure	Placebo n=12 Participants Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 Participants Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 Participants Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 Participants Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Number of Participants With at Least One Positive Anti-Jo-1 Antibodies Titers	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Efzofitimod 1.0 mg/kg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Efzofitimod 3.0 mg/kg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Efzofitimod 5.0 mg/kg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=12 participants at risk Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 participants at risk Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 participants at risk Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 participants at risk Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Streptococcal sepsis	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.

Other adverse events

Measure	Placebo n=12 participants at risk Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20.	Efzofitimod 1.0 mg/kg n=8 participants at risk Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 3.0 mg/kg n=8 participants at risk Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20.	Efzofitimod 5.0 mg/kg n=9 participants at risk Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	50.0% 4/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	25.0% 2/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	50.0% 4/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	25.0% 2/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	22.2% 2/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Productive cough	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
General disorders Fatigue	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	25.0% 2/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	44.4% 4/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
General disorders Pyrexia	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
General disorders Feeling hot	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
General disorders Pain	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
General disorders Peripheral swelling	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
General disorders Vaccination site reaction	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
General disorders Feeling jittery	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Upper respiratory tract infection	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	25.0% 2/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Bronchitis	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Abdominal wall abscess	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Influenza	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Sputum purulent	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Candida infection	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Infections and infestations Metapneumovirus infection	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	25.0% 2/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	25.0% 2/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Musculoskeletal and connective tissue disorders Neck pain	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Nervous system disorders Dizziness	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	22.2% 2/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Nervous system disorders Headache	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	25.0% 2/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Nervous system disorders Burning sensation	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Nervous system disorders Disturbance in attention	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Nervous system disorders Paraesthesia	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Nervous system disorders Syncope	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Nervous system disorders Migraine	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Gastrointestinal disorders Abdominal hernia	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Gastrointestinal disorders Nausea	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Gastrointestinal disorders Salivary gland mass	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Gastrointestinal disorders Toothache	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Lymphocyte count decreased	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Activated partial thromboplastin time prolonged	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Blood bilirubin increased	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Electrocardiogram T wave abnormal	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Eosinophil count increased	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Laboratory test abnormal	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Neutrophil count increased	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Protein urine present	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Prothrombin time prolonged	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Alanine aminotransferase increased	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Aspartate aminotransferase increased	16.7% 2/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Biopsy skin	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Blood lactate dehydrogenase increased	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Breath sounds abnormal	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Gamma-glutamyltransferase increased	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Mean cell volume increased	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations Oxygen saturation decreased	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Investigations White blood cell count decreased	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Eye disorders Narrow anterior chamber angle	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Eye disorders Scleritis	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Eye disorders Cataract	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Eye disorders Dry eye	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Metabolism and nutrition disorders Hypertriglyceridaemia	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	11.1% 1/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Skin and subcutaneous tissue disorders Eczema	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Skin and subcutaneous tissue disorders Rash pruritic	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Skin and subcutaneous tissue disorders Urticaria	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Immune system disorders Sarcoidosis	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Psychiatric disorders Depression	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Renal and urinary disorders Pollakiuria	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Renal and urinary disorders Proteinuria	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	12.5% 1/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Blood and lymphatic system disorders Lymphopenia	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Cardiac disorders Bradycardia	8.3% 1/12 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/8 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.	0.00% 0/9 • Baseline up to Week 24 The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.

Additional Information

Lisa Carey

aTyR Pharma

Phone: 858 731 8389

Email: clinicaltrials@atyrpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place