Trial Outcomes & Findings for An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. (NCT NCT05562934)

Last Updated: 2026-01-12

Results Overview

To evaluate the efficacy and dose-response relationship of different doses of XXB750 compared to placebo in reducing the mean 24 hours ambulatory systolic blood pressure from baseline at Week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device. The primary outcome measure was evaluated using an optimally weighted contrast test following the Multiple Comparison Procedure-Modeling (MCP-MOD) methodology. There were five candidate models to capture the shape of the dose-response relationship for XXB750 at Week 12 endpoint. The outcome for the single best candidate model is shown in the Statistical Analysis section.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

189 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2026-01-12

Participant Flow

Participants took part in 135 investigative sites in 16 countries.

The study consisted of a screening period of approximately 7 days.

Participant milestones

Participant milestones
Measure	Placebo Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
Overall Study NOT COMPLETED	0	2	1	2	4
Overall Study STARTED	42	32	36	37	42
Overall Study COMPLETED	42	30	35	35	38

Reasons for withdrawal

Reasons for withdrawal
Measure	XXB750 30 mg XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
Overall Study Adverse Event	2	0	0	2
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Protocol Violation	0	0	1	1
Overall Study Withdrawal by Subject	0	1	1	0

Baseline Characteristics

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=42 Participants Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg n=32 Participants XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg n=36 Participants XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg n=37 Participants XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg n=42 Participants XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.	Total n=189 Participants Total of all reporting groups
Age, Continuous	60.14 years STANDARD_DEVIATION 10.862 • n=210 Participants	58.53 years STANDARD_DEVIATION 11.565 • n=19 Participants	63.44 years STANDARD_DEVIATION 10.191 • n=8 Participants	62.41 years STANDARD_DEVIATION 11.642 • n=24 Participants	60.64 years STANDARD_DEVIATION 10.085 • n=5716 Participants	61.05 years STANDARD_DEVIATION 10.863 • n=47026 Participants
Sex: Female, Male Female	13 Participants n=210 Participants	8 Participants n=19 Participants	6 Participants n=8 Participants	18 Participants n=24 Participants	13 Participants n=5716 Participants	58 Participants n=47026 Participants
Sex: Female, Male Male	29 Participants n=210 Participants	24 Participants n=19 Participants	30 Participants n=8 Participants	19 Participants n=24 Participants	29 Participants n=5716 Participants	131 Participants n=47026 Participants
Race/Ethnicity, Customized Black Or African American	6 Participants n=210 Participants	7 Participants n=19 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	6 Participants n=5716 Participants	27 Participants n=47026 Participants
Race/Ethnicity, Customized White	27 Participants n=210 Participants	16 Participants n=19 Participants	24 Participants n=8 Participants	24 Participants n=24 Participants	25 Participants n=5716 Participants	116 Participants n=47026 Participants
Race/Ethnicity, Customized Asian	8 Participants n=210 Participants	5 Participants n=19 Participants	6 Participants n=8 Participants	8 Participants n=24 Participants	10 Participants n=5716 Participants	37 Participants n=47026 Participants
Race/Ethnicity, Customized Other	1 Participants n=210 Participants	4 Participants n=19 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=5716 Participants	9 Participants n=47026 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set (FAS): All participants to whom study treatment was assigned by randomization. Only participants with a valid assessment for this endpoint were included.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg n=25 Participants XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg n=30 Participants XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg n=32 Participants XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg n=36 Participants XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
Dose-response (DR) Relationship of XXB750 With Respect to Change From Baseline in Systolic Blood Pressure (SBP) 24 Hours	-5.77 mmHg Interval -10.74 to -1.12	-6.41 mmHg Interval -10.15 to -2.85	-6.63 mmHg Interval -10.4 to -3.53	-6.66 mmHg Interval -12.57 to -3.16	-5.40 mmHg Interval -9.58 to -0.36

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set (FAS): All participants to whom study treatment was assigned by randomization. Only participants from the highest XXB750 dose and placebo with valid measurements are included.

To evaluate the treatment effect of the highest XXB750 dose versus placebo in reducing the mean 24 hours SBP from baseline to Week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg n=36 Participants XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
Change From Baseline in SBP 24 Hours at Week 12 (Difference Between Highest XXB750 Dose and Placebo)	-6.01 mmHg Standard Error 2.42	-4.64 mmHg Standard Error 2.49	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 9 and Week 12

To evaluate the treatment effect of the highest XXB750 dose versus placebo in the dosing interval average of ambulatory SBP as assessed by average of mean 24 hours SBP measured at week 9 and week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg n=38 Participants XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
Change From Baseline in SBP 24 Hours of Average of Week 9 and Week 12 (Difference Between Highest XXB750 Dose and Placebo)	-5.77 mmHg Standard Error 2.13	-4.62 mmHg Standard Error 2.21	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set (FAS): All participants to whom study treatment was assigned by randomization.

To evaluate the percentage of participants achieving ambulatory BP control defined as mean 24 hours SBP \<130 mmHg and mean 24 hours DBP \< 80 mmHg with respect to the dose-response relationship of the four XXB750 dose level groups compared to placebo at week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device. Percentage of participants is derived from dose response analysis, using generalized MCP-Mod methodology for binary data.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg n=25 Participants XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg n=30 Participants XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg n=32 Participants XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg n=36 Participants XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
The Model-based Estimated Percentage of Participants Achieving Blood Pressure (BP) Control	13.2 percentage	15.0 percentage	17.7 percentage	22.0 percentage	25.9 percentage

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

XXB750 30 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

XXB750 60 mg

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

XXB750 120 mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

XXB750 120 mg/240 mg

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=42 participants at risk Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg n=32 participants at risk XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg n=36 participants at risk XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg n=37 participants at risk XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg n=42 participants at risk XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
Cardiac disorders Cardiac failure	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Coronary artery disease	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Device related infection	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Infectious pleural effusion	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Osteomyelitis acute	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Pneumonia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	7.1% 3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Dehydration	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Exertional rhabdomyolysis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Dizziness	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Syncope	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Acute kidney injury	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.

Other adverse events

Other adverse events
Measure	Placebo n=42 participants at risk Placebo subcutaneous (s.c) every 4 weeks, total of 3 doses.	XXB750 30 mg n=32 participants at risk XXB750 30 mg s.c every 4 weeks, total of 3 doses.	XXB750 60 mg n=36 participants at risk XXB750 60 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg n=37 participants at risk XXB750 120 mg s.c every 4 weeks, total of 3 doses.	XXB750 120 mg/240 mg n=42 participants at risk XXB750 120 mg s.c at the randomization visit followed by 240 mg s.c at Week 4 and Week 8.
Vascular disorders Hypertension	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Atrial fibrillation	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	6.2% 2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Vascular disorders Hypotension	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Bradycardia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Cardiac failure	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Diastolic dysfunction	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Myocardial ischaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Palpitations	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Sinus bradycardia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Ear and labyrinth disorders Vertigo	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Eye disorders Eyelid oedema	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Cardiac disorders Angina pectoris	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Gastrointestinal disorders Diarrhoea	7.1% 3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Gastrointestinal disorders Toothache	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Asthenia	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Fatigue	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Influenza like illness	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Injection site pain	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Injection site pruritus	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Injection site reaction	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Malaise	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Oedema peripheral	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	8.3% 3/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	5.4% 2/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
General disorders Pyrexia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Hepatobiliary disorders Liver disorder	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Acute sinusitis	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Bronchitis	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations COVID-19	9.5% 4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	7.1% 3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Carbuncle	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Cellulitis	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Conjunctivitis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Erysipelas	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Gastroenteritis	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Infected bite	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Influenza	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Injection site cellulitis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Laryngitis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Nasopharyngitis	4.8% 2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Oral candidiasis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Pharyngitis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Pneumonia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Pneumonia aspiration	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Tooth infection	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Upper respiratory tract infection	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	5.4% 2/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Urinary tract infection	9.5% 4/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	10.8% 4/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Infections and infestations Wound infection	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Injury, poisoning and procedural complications Ankle fracture	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Injury, poisoning and procedural complications Burns first degree	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Injury, poisoning and procedural complications Joint injury	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Injury, poisoning and procedural complications Vaccination complication	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Alanine aminotransferase increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Amylase increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Blood creatine phosphokinase increased	7.1% 3/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Blood creatinine increased	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	6.2% 2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Blood iron abnormal	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Blood pressure increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Electrocardiogram PR prolongation	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Electrocardiogram ST-T segment elevation	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Electrocardiogram abnormal	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Glucose urine present	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Haematocrit increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Haemoglobin increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Heart rate abnormal	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Heart sounds abnormal	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Lipase increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Liver function test increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Protein urine present	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Prothrombin time prolonged	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	4.8% 2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Investigations Transaminases increased	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Dehydration	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Gout	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hypercholesterolaemia	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hyperkalaemia	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	5.6% 2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hyperlipidaemia	4.8% 2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	4.8% 2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Hypokalaemia	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	5.6% 2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	8.1% 3/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Metabolism and nutrition disorders Vitamin D deficiency	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Psychiatric disorders Insomnia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	6.2% 2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glomus tumour	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Cervical radiculopathy	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Dizziness	4.8% 2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	9.4% 3/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	5.6% 2/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	4.8% 2/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Headache	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	6.2% 2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Hypoaesthesia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Hypotonia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Paraesthesia	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Sciatica	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Syncope	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Nervous system disorders Vertebral artery occlusion	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Psychiatric disorders Irritability	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Albuminuria	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Azotaemia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Dysuria	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Nocturia	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Proteinuria	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	5.4% 2/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Renal cyst	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Renal failure	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Reproductive system and breast disorders Balanoposthitis	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Reproductive system and breast disorders Erectile dysfunction	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders Cough	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	8.1% 3/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Skin and subcutaneous tissue disorders Dermatitis contact	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Skin and subcutaneous tissue disorders Rash	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Skin and subcutaneous tissue disorders Skin swelling	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Skin and subcutaneous tissue disorders Solar urticaria	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	3.1% 1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Vascular disorders Aortic arteriosclerosis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.7% 1/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Vascular disorders Deep vein thrombosis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Vascular disorders Orthostatic hypotension	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.8% 1/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.
Vascular disorders Phlebitis	0.00% 0/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/36 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	0.00% 0/37 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.	2.4% 1/42 • Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER