Trial Outcomes & Findings for A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension (NCT NCT03657095)

NCT ID: NCT03657095

Last Updated: 2020-09-07

Results Overview

A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) is an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), or persistent or significant disability/incapacity. AEs included both SAEs and non-serious AEs. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 112 participants
• Primary outcome timeframe: Baseline up to Month 7
• Results posted on: 2020-09-07

Participant Flow

At the Enrollment Visit for this open-label extension (OLE) study, participants began a blinded transition from the pivotal BPS-314d-MR-PAH-302 double-blind study (NCT01908699) to this study over 4 weeks.

Participant milestones

Measure	Esuberaprost Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 microgram (μg) esuberaprost sodium tablets for oral administration 4 times daily (QID) for up to 7 months (which included the 4 weeks of blinded transition).	Placebo/Esuberaprost Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
Overall Study STARTED	59	53
Overall Study Received at Least 1 Dose of Study Drug	59	53
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	59	53

Reasons for withdrawal

Measure	Esuberaprost Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 microgram (μg) esuberaprost sodium tablets for oral administration 4 times daily (QID) for up to 7 months (which included the 4 weeks of blinded transition).	Placebo/Esuberaprost Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	3
Overall Study Study Terminated by Sponsor	58	49

Baseline Characteristics

A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension

Baseline characteristics by cohort

Measure	Esuberaprost n=59 Participants Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).	Placebo/Esuberaprost n=53 Participants Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).	Total n=112 Participants Total of all reporting groups
Age, Continuous	59.0 years STANDARD_DEVIATION 11.02 • n=5 Participants	62.5 years STANDARD_DEVIATION 9.75 • n=7 Participants	60.6 years STANDARD_DEVIATION 10.54 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	49 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	44 Participants n=7 Participants	93 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Month 7

Population: All participants who receive at least 1 dose of study drug.

A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) is an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), or persistent or significant disability/incapacity. AEs included both SAEs and non-serious AEs. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Measure	Esuberaprost n=59 Participants Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).	Placebo/Esuberaprost n=53 Participants Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) TEAEs	56 Participants	52 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Treatment-Emergent SAEs	9 Participants	8 Participants

SECONDARY outcome

Timeframe: Week 4 and then every 3 months until study termination (Month 7)

Population: All participants who receive at least 1 dose of study drug. Efficacy data was not collected or analyzed for this extension study.

Area used for the Six Minute Walk Test (6MWT) were to be pre-measured at 30 meters in length. Rest periods were to be allowed if participant could no longer continue. If participant needed to rest, he/she could have stood or sit and then begin again when rested but the clock would continue to run. At the end of 6 minutes, the tester was to call "stop" while stopping the watch and then measure the distance walked. Distance <500 meters would have suggested considerable exercise limitation; distance 500-800 meters would have suggested moderate limitation; and distance >800 meters (with no rests) would have suggested mild or no limitation. This extension study was terminated early due to the pivotal double-blind study failed to demonstrate efficacy. Therefore, efficacy data was not collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4 and then every 3 months until study termination (Month 7)

Population: All participants who receive at least 1 dose of study drug. Efficacy data was not collected or analyzed for this extension study.

The modified 0-10 category-ratio Borg scale is one in which the participants were to rate the maximum level of dyspnea they experienced during the 6MWT. Scores would have ranged from 0 (for the best condition) and 10 (for the worst condition). This extension study was terminated early due to the pivotal double-blind study failed to demonstrate efficacy. Therefore, efficacy data was not collected or analyzed. Note, a summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4 and then every 3 months until study termination (Month 7)

Population: All participants who receive at least 1 dose of study drug. Efficacy data was not collected or analyzed for this extension study.

The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. This extension study was terminated early due to the pivotal double-blind study failed to demonstrate efficacy. Therefore, efficacy data was not collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Month 7

Population: All participants who receive at least 1 dose of study drug.

A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Measure	Esuberaprost n=59 Participants Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).	Placebo/Esuberaprost n=53 Participants Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
Number of Participants With a TEAE of N-terminal Pro-brain Natriuretic Peptide (NT-pro-BNP) Increased	5 Participants	2 Participants

Adverse Events

Esuberaprost

Serious events: 12 serious events

Other events: 56 other events

Deaths: 0 deaths

Placebo/Esuberaprost

Serious events: 8 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Esuberaprost n=59 participants at risk Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).	Placebo/Esuberaprost n=53 participants at risk Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
Respiratory, thoracic and mediastinal disorders Asthma	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Atrial flutter	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Coronary artery compression	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Pericardial effusion	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Pneumonia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Metapneumovirus infection	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Delirium	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Peripheral swelling	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Peripheral vascular disorder	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.

Other adverse events

Measure	Esuberaprost n=59 participants at risk Participants who received esuberaprost during the BPS-314d-MR-PAH-302 double-blind study received 2 tablets of 15 μg esuberaprost sodium tablets for oral administration QID for up to 7 months (which included the 4 weeks of blinded transition).	Placebo/Esuberaprost n=53 participants at risk Participants who received placebo during the BPS-314d-MR-PAH-302 double-blind study received 1 esuberaprost tablet and 1 placebo tablet QID for the first 2 weeks of the blinded transition and then received 2 esuberaprost tablets QID for the rest of the study, for up to 7 months (which included the other 2 weeks of the total 4-week blinded transition).
Gastrointestinal disorders Diarrhoea	15.3% 9/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	22.6% 12/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Nausea	11.9% 7/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	15.1% 8/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Constipation	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoids	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Faeces soft	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Hiatus hernia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Inguinal hernia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Irritable bowel syndrome	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Lip swelling	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Mouth ulceration	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Mucous stools	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Tongue coated	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Tongue ulceration	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Tooth loss	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Headache	35.6% 21/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	32.1% 17/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Dizziness	15.3% 9/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	17.0% 9/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Disturbance in attention	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Amputation stump pain	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Cervical radiculopathy	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Dysgeusia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Dyskinesia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Facial paralysis	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Lethargy	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Lumbar radiculopathy	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Migraine	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Nerve compression	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Peroneal nerve palsy	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Presyncope	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Sciatica	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Nervous system disorders Tremor	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.6% 11/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	13.2% 7/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	15.3% 9/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	11.3% 6/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.8% 4/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	7.5% 4/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dry throat	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung cyst	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rales	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	16.9% 10/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	11.3% 6/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	9.4% 5/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	6.8% 4/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	7.5% 4/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	8.5% 5/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteopenia	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.8% 4/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Dysphagia	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Gastric polyps	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Glossitis	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Gastrointestinal disorders Glossodynia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Haematocrit decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Heart rate increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Heart sounds abnormal	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations International normalised ratio increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Sclerodactylia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Scleroderma	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Tendonitis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Fatigue	15.3% 9/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	17.0% 9/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Oedema peripheral	11.9% 7/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	11.3% 6/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Chest discomfort	6.8% 4/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Pain	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	7.5% 4/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Peripheral swelling	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Non-cardiac chest pain	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Asthenia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Oedema	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Calcinosis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Crepitations	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Cyst	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Disease progression	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Feeling abnormal	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Feeling cold	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Localised oedema	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
General disorders Swelling	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Sinusitis	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	7.5% 4/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	7.5% 4/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Influenza	6.8% 4/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Pneumonia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Urinary tract infection	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Diverticulitis	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Ear infection	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Herpes virus infection	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Acute sinusitis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Cellulitis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Chronic sinusitis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Clostridium difficile colitis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Clostridium difficile infection	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Groin abscess	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Helminthic infection	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Localised infection	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Metapneumovirus infection	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Nasal vestibulitis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Onychomycosis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Otitis media	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Pharyngitis streptococcal	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Infections and infestations Viral upper respiratory tract infection	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations N-terminal prohormone brain natriuretic peptide increased	8.5% 5/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Weight increased	6.8% 4/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood creatinine increased	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood urea increased	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood uric acid increased	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Haemoglobin decreased	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Electrocardiogram T wave inversion	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Gamma-glutamyltransferase increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Haematocrit increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Haemoglobin increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Activated partial thromboplastin time prolonged	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Antinuclear antibody positive	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood HIV RNA increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood glucose increased	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood iron decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Blood potassium decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations CD4 lymphocytes decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Carbon dioxide decreased	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Exostosis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Cardiac murmur	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint swelling	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Electrocardiogram QT prolonged	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Limb discomfort	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Flushing	15.3% 9/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Hot flush	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	7.5% 4/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Hypertension	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Varicose vein	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Peripheral vascular disorder	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Peripheral venous disease	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Vascular disorders Subclavian artery stenosis	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Palpitations	10.2% 6/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Bradycardia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Atrial flutter	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Ventricular extrasystoles	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Bundle branch block left	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Cardiomyopathy	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Coronary artery compression	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Coronary ostial stenosis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Pericardial effusion	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Right ventricular dysfunction	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Supraventricular extrasystoles	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Vitamin D deficiency	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Fluid overload	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Gout	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Fluid retention	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Depression	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Anxiety	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Insomnia	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Abnormal dreams	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Delirium	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Psychiatric disorders Libido decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Acne	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Blister	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Erythema	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Intertrigo	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus generalised	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash papular	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Mean cell haemoglobin concentration decreased	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Neutrophil count decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Oxygen saturation decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Protein urine	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Prothrombin time abnormal	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Prothrombin time prolonged	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations QRS axis abnormal	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Serum ferritin decreased	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Investigations Weight decreased	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Ulna fracture	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Joint dislocation	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Muscle rupture	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Muscle strain	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Pubis fracture	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Seroma	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Eye disorders Dry eye	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Eye disorders Eye irritation	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Eye disorders Vision blurred	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Eye disorders Cataract	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Eye disorders Conjunctival haemorrhage	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Eye disorders Glaucoma	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin discolouration	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin fissures	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin tightness	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	6.8% 4/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	5.7% 3/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Blood and lymphatic system disorders Polycythaemia	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphocytosis	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Foot fracture	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Injury, poisoning and procedural complications Ligament sprain	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Joint neoplasm	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Immune system disorders Seasonal allergy	5.1% 3/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Immune system disorders Hypersensitivity	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Immune system disorders Drug hypersensitivity	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Renal and urinary disorders Renal cyst	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	3.8% 2/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Renal and urinary disorders Hypercalciuria	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Renal and urinary disorders Hypertonic bladder	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Renal and urinary disorders Hypocitraturia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Renal and urinary disorders Nocturia	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Ear and labyrinth disorders Ear discomfort	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Ear and labyrinth disorders Hypoacusis	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Endocrine disorders Hyperparathyroidism	3.4% 2/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Endocrine disorders Hypothyroidism	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Endocrine disorders Adrenal insufficiency	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Endocrine disorders Thyroid mass	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/16 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	7.1% 1/14 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Reproductive system and breast disorders Breast haematoma	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Reproductive system and breast disorders Breast mass	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/43 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	2.6% 1/39 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Reproductive system and breast disorders Postmenopausal haemorrhage	2.3% 1/43 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/39 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Congenital, familial and genetic disorders Corneal dystrophy	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Congenital, familial and genetic disorders Tornwaldt cyst	1.7% 1/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	0.00% 0/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/59 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.	1.9% 1/53 • Baseline up to Month 7 Adverse events were collected from all participants who receive at least 1 dose of study drug.

Additional Information

Lung Biotechnology PBC

Lung Biotechnology PBC Study Director

Phone: 301-608-9292

Email: info@lungbiotechnology.com

Results disclosure agreements

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

Restriction type: GT60