Trial Outcomes & Findings for Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia (NCT NCT02961218)

NCT ID: NCT02961218

Last Updated: 2026-01-13

Results Overview

Visual analog scale (VAS) was used to record severity. Pediatric and young adult participants rated their daily sickle cell associated pain intensity once each day in the evening using an 11-point numerical rating scale from 0 to 10 with higher ratings associated with more intense pain (0 = no pain, 10 = worst pain). For each subject, there was a maximum 28-day screening period that included recording of daily pain intensity by e-diary for at least 1 week. The average daily pain results in the screening period were used to derive the baseline value. The average over week 8 to 12 was calculated and the change from baseline in the average daily pain VAS was analyzed using a Bayesian model for repeated measures.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 49 participants
• Primary outcome timeframe: Baseline (upto 28 days prior to start of treatment), Week 8 to 12
• Results posted on: 2026-01-13

Participant Flow

A total of 49 participants were randomized into the study from 15 centers in seven countries: Greater Britain (5), Israel (1), Germany (1), Turkey (3), South Africa (1), USA (3) and Canada (1).

Subjects who met the eligibility criteria at screening underwent evaluation of baseline clinical and biomarker assessments prior to first dose administration.

Participant milestones

Measure	ACZ885 Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Overall Study STARTED	25	24
Overall Study Safety Analysis Set	25	24
Overall Study Pharmacokinetics (PK) Analysis Set	25	0
Overall Study Primary PD Analysis Set	25	24
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	ACZ885 Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Overall Study Lost to Follow-up	0	2
Overall Study Physician Decision	0	2
Overall Study Subject/Guardian Decision	3	1

Baseline Characteristics

Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia

Baseline characteristics by cohort

Measure	ACZ885 n=25 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=24 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.	Total n=49 Participants Total of all reporting groups
Age, Continuous	15.8 Years STANDARD_DEVIATION 2.69 • n=210 Participants	15.6 Years STANDARD_DEVIATION 3.28 • n=19 Participants	15.7 Years STANDARD_DEVIATION 2.97 • n=123 Participants
Sex: Female, Male Female	10 Participants n=210 Participants	11 Participants n=19 Participants	21 Participants n=123 Participants
Sex: Female, Male Male	15 Participants n=210 Participants	13 Participants n=19 Participants	28 Participants n=123 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=210 Participants	13 Participants n=19 Participants	25 Participants n=123 Participants
Race/Ethnicity, Customized White	12 Participants n=210 Participants	10 Participants n=19 Participants	22 Participants n=123 Participants
Race/Ethnicity, Customized Other	1 Participants n=210 Participants	1 Participants n=19 Participants	2 Participants n=123 Participants

PRIMARY outcome

Timeframe: Baseline (upto 28 days prior to start of treatment), Week 8 to 12

Population: Pharmacodynamics (PD) analysis set: included all subjects with available PD data, who received any study drug.

Visual analog scale (VAS) was used to record severity. Pediatric and young adult participants rated their daily sickle cell associated pain intensity once each day in the evening using an 11-point numerical rating scale from 0 to 10 with higher ratings associated with more intense pain (0 = no pain, 10 = worst pain). For each subject, there was a maximum 28-day screening period that included recording of daily pain intensity by e-diary for at least 1 week. The average daily pain results in the screening period were used to derive the baseline value. The average over week 8 to 12 was calculated and the change from baseline in the average daily pain VAS was analyzed using a Bayesian model for repeated measures.

Outcome measures

Measure	ACZ885 n=25 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=24 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change From Baseline of 4- Week Average Daily Pain Measured by Visual Analog Score (VAS) Over the Period of Week 8 to 12	-0.45 Score on a scale Standard Deviation 0.384	-0.37 Score on a scale Standard Deviation 0.402

SECONDARY outcome

Timeframe: Baseline (upto 28 days prior to start of treatment), Week 0 to 4, Week 4 to 8, Week 8 to 12, Week 12 to 16, Week 16 to 20 and Week 20 to 24

Population: Pharmacodynamics (PD) analysis set: included all subjects with available PD data, who received any study drug.

Visual analog scale (VAS) was used to record severity. Pediatric and young adult participants rated their daily sickle cell associated pain intensity once each day in the evening using an 11-point numerical rating scale from 0 to 10 with higher ratings associated with more intense pain (0 = no pain, 10 = worst pain). The average of 4 weeks interval up to week 24 was calculated.

Outcome measures

Measure	ACZ885 n=25 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=24 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24 0-4 Weeks	-0.337 Score on a scale Standard Deviation 1.629	0.007 Score on a scale Standard Deviation 1.428
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24 4-8 Weeks	-0.173 Score on a scale Standard Deviation 1.515	0.158 Score on a scale Standard Deviation 1.847
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24 8-12 Weeks	-0.444 Score on a scale Standard Deviation 1.437	-0.376 Score on a scale Standard Deviation 2.104
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24 12-16 Weeks	-0.505 Score on a scale Standard Deviation 1.744	0.057 Score on a scale Standard Deviation 2.371
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24 16-20 Weeks	-0.388 Score on a scale Standard Deviation 1.772	0.151 Score on a scale Standard Deviation 1.811
Change From Baseline of Average Daily Pain VAS Over 4 Weeks Intervals up to Week 24 20-24 Weeks	-0.752 Score on a scale Standard Deviation 1.678	0.036 Score on a scale Standard Deviation 2.131

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

hs-CRP is a biomarker that represents the inflammation process.

Outcome measures

Measure	ACZ885 n=20 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to Week 12	0.338 mg/L Interval 0.237 to 0.483	0.830 mg/L Interval 0.576 to 1.194

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

WBC count was used as a laboratory marker to determine the effect of the drug

Outcome measures

Measure	ACZ885 n=19 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=17 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of White Blood Cell (WBC) Count From Baseline to Week 12	0.813 10^9 cells/liter Interval 0.737 to 0.898	1.081 10^9 cells/liter Interval 0.973 to 1.201

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

Absolute count of neutrophils was measured as a laboratory marker to determine the effect of the drug

Outcome measures

Measure	ACZ885 n=19 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=17 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of Absolute Count of Neutrophils From Baseline to Week 12	0.717 10^9 cells/liter Interval 0.611 to 0.842	1.052 10^9 cells/liter Interval 0.888 to 1.246

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

Absolute count of blood monocytes was measured as a laboratory marker to determine the effect of the drug.

Outcome measures

Measure	ACZ885 n=19 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=17 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of Absolute Count of Blood Monocytes From Baseline to Week 12	0.712 10^9 cells/liter Interval 0.59 to 0.859	0.992 10^9 cells/liter Interval 0.813 to 1.209

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

Hemoglobin was used as a hemolysis marker to determine the effect of the drug.

Outcome measures

Measure	ACZ885 n=19 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of Hemoglobin From Baseline to Week 12	-0.97 g/L Standard Deviation 4.727	1.11 g/L Standard Deviation 7.975

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

Reticulocyte count was used as a hemolysis marker to determine the effect of the drug

Outcome measures

Measure	ACZ885 n=18 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Reticulocyte Count From Baseline to Week 12	-6.578 10^9 cells/liter Standard Deviation 64.1131	25.358 10^9 cells/liter Standard Deviation 47.6483

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

Bilirubin was used as a hemolysis marker to determine the effect of the drug

Outcome measures

Measure	ACZ885 n=20 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of Bilirubin From Baseline to Week 12	5.05 umol/L Standard Deviation 19.796	-1.95 umol/L Standard Deviation 11.591

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

LDH was used as a hemolysis marker to determine the effect of the drug

Outcome measures

Measure	ACZ885 n=18 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of Lactate Dehydrogenase (LDH) From Baseline to Week 12	19.06 Units per liter (U/L) Standard Deviation 70.862	-33.74 Units per liter (U/L) Standard Deviation 209.259

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

Haptoglobin was used as a hemolysis marker to determine the effect of the drug

Outcome measures

Measure	ACZ885 n=13 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of Haptoglobin From Baseline to Week 12	-0.0112 g/L Standard Deviation 0.04022	-0.0213 g/L Standard Deviation 0.07923

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

SAO2 was used as a hemolysis marker to determine the effect of the drug

Outcome measures

Measure	ACZ885 n=20 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Change in the Concentration of Oxygen Percent Saturation (SAO2) From Baseline to Week 12	-0.5 Oxygen Saturation Percent Standard Deviation 2.16	-0.3 Oxygen Saturation Percent Standard Deviation 1.82

SECONDARY outcome

Timeframe: up to Week 24

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

The number of SCA-related days absent from school or work were derived from eDiary records.

Outcome measures

Measure	ACZ885 n=22 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=19 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Number of Days Absent From School or Work Due to Pain as Recorded by E-diary	2.20 Days Interval 1.69 to 2.7	1.86 Days Interval 1.31 to 2.41

SECONDARY outcome

Timeframe: 12 weeks

Population: Pharmacodynamics (PD) analysis including patients with a valid measurements for the outcome measure

The occurrence of acute blood transfusions was summarized as the proportion of subjects who received at least one acute blood transfusion and the event rate of acute blood transfusions per subject, by study period, group and reason of transfusion.

Outcome measures

Measure	ACZ885 n=25 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=24 Participants Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Overall Acute blood transfusion · 0 transfusions	20 Participants	18 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Overall Acute blood transfusion · 1 transfusion	4 Participants	4 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Overall Acute blood transfusion · 2 transfusions	1 Participants	1 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Overall Acute blood transfusion · 3 transfusions	0 Participants	1 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Rescue · 0 transfusions	23 Participants	19 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Rescue · 1 transfusion	2 Participants	4 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Rescue · 2 transfusions	0 Participants	1 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Rescue · 3 transfusions	0 Participants	0 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Prophylactic · 0 transfusions	22 Participants	22 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Prophylactic · 1 transfusion	2 Participants	1 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Prophylactic · 2 transfusions	1 Participants	1 Participants
Number of Acute Blood Transfusions Per Patient by Study Period - Double-blind Period Acute blood transfusion: Prophylactic · 3 transfusions	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 20 and 24

Population: Pharmacokinetics (PK) analysis set consisted of ACZ885 treated patients. Placebo patients were excluded from the PK analysis

PK samples were collected at Baseline, Week 4, 12, 20 and 24. Mean and standard deviation of the ACZ885 concentration was reported. Only those participants available at the specified time points were analyzed

Outcome measures

Measure	ACZ885 n=25 Participants Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo Monthly doses of placebo to match the administered dose of ACZ885 s.c.
Mean Serum Concentration After Repeated Dosing of ACZ885 Baseline	0 ng/mL Standard Deviation 0	—
Mean Serum Concentration After Repeated Dosing of ACZ885 Week 4	13100 ng/mL Standard Deviation 5490	—
Mean Serum Concentration After Repeated Dosing of ACZ885 Week 12	18700 ng/mL Standard Deviation 5860	—
Mean Serum Concentration After Repeated Dosing of ACZ885 Week 20	19700 ng/mL Standard Deviation 5810	—
Mean Serum Concentration After Repeated Dosing of ACZ885 Week 24	20600 ng/mL Standard Deviation 5930	—

Adverse Events

ACZ885

Serious events: 11 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 15 serious events

Other events: 20 other events

Deaths: 0 deaths

ACZ885 / ACZ885

Serious events: 11 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo / ACZ885

Serious events: 11 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	ACZ885 n=25 participants at risk Double-blind period (Week 0 to 24): Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=24 participants at risk Double-blind period (Week 0 to 24): Monthly doses of placebo to match the administered dose of ACZ885 s.c.	ACZ885 / ACZ885 n=22 participants at risk Open label Phase (after Week 24 to Week 56) for the participants originally randomized to ACZ885: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo / ACZ885 n=20 participants at risk Open label Phase (after Week 24 to Week 56) for the participants originally randomized to placebo: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
General disorders Asthenia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	40.0% 10/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	45.8% 11/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	40.9% 9/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	50.0% 10/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Pyrexia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Hepatobiliary disorders Cholelithiasis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Immune system disorders Alloimmunisation	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Lower respiratory tract infection	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Pneumonia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Sinusitis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Upper respiratory tract infection	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Alanine aminotransferase increased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Dizziness	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Headache	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Reproductive system and breast disorders Priapism	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	8.3% 2/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.

Other adverse events

Measure	ACZ885 n=25 participants at risk Double-blind period (Week 0 to 24): Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo n=24 participants at risk Double-blind period (Week 0 to 24): Monthly doses of placebo to match the administered dose of ACZ885 s.c.	ACZ885 / ACZ885 n=22 participants at risk Open label Phase (after Week 24 to Week 56) for the participants originally randomized to ACZ885: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects	Placebo / ACZ885 n=20 participants at risk Open label Phase (after Week 24 to Week 56) for the participants originally randomized to placebo: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
Blood and lymphatic system disorders Anaemia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Blood and lymphatic system disorders Leukopenia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Blood and lymphatic system disorders Neutropenia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Cardiac disorders Bradycardia	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Eye disorders Eye pain	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Eye disorders Ocular hyperaemia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Eye disorders Periorbital oedema	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Eye disorders Vision blurred	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	15.0% 3/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	8.3% 2/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Constipation	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	10.0% 2/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Diarrhoea	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Dyspepsia	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Gastritis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Gingival bleeding	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Haemorrhoids	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Lip swelling	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Nausea	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	8.3% 2/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	10.0% 2/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Swollen tongue	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Toothache	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Fatigue	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	8.3% 2/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Injection site pain	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Injection site pruritus	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Medical device site irritation	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Non-cardiac chest pain	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	10.0% 2/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Pain	24.0% 6/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	20.8% 5/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	13.6% 3/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	35.0% 7/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
General disorders Pyrexia	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Hepatobiliary disorders Cholelithiasis	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Immune system disorders Allergy to metals	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Conjunctivitis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Gastrointestinal infection	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Influenza	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	10.0% 2/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Lower respiratory tract infection	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Nasopharyngitis	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Oral candidiasis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Oral herpes	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Otitis media	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Pneumonia	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Respiratory tract infection	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Sinusitis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Tonsillitis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Tooth abscess	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Upper respiratory tract infection	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	20.8% 5/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	30.0% 6/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Urinary tract infection	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Viral infection	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Infections and infestations Viral upper respiratory tract infection	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Psychiatric disorders Pica	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Alanine aminotransferase increased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Blood bilirubin increased	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Blood creatine phosphokinase increased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Blood pressure increased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Cardiac murmur	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Haemoglobin decreased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Oxygen saturation abnormal	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Oxygen saturation decreased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Spleen palpable	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Transaminases increased	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Ultrasound Doppler abnormal	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Urine albumin/creatinine ratio increased	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	8.3% 2/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Vitamin B12 decreased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations Vitamin D decreased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Investigations White blood cell count decreased	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Increased appetite	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Vitamin B complex deficiency	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	10.0% 2/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Back pain	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	8.3% 2/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	25.0% 5/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Bone infarction	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Degenerative bone disease	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Muscle swelling	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.0% 2/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Neck pain	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Osteoporosis	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Pain in extremity	12.0% 3/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	12.5% 3/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	15.0% 3/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lymph node neoplasm	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Benign enlargement of the subarachnoid spaces	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Dizziness	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	10.0% 2/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Headache	20.0% 5/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	12.5% 3/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	9.1% 2/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	20.0% 4/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Lethargy	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Migraine	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Nervous system disorders Spinal cord oedema	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Psychiatric disorders Bipolar disorder	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Psychiatric disorders Depression	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Psychiatric disorders Illness anxiety disorder	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Renal and urinary disorders Dysuria	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Renal and urinary disorders Nephropathy	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Renal and urinary disorders Renal colic	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Renal and urinary disorders Urinary retention	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Reproductive system and breast disorders Polymenorrhoea	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Reproductive system and breast disorders Priapism	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	8.3% 2/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	10.0% 2/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Skin and subcutaneous tissue disorders Rash	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Skin and subcutaneous tissue disorders Urticaria	4.0% 1/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.2% 1/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	5.0% 1/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.
Vascular disorders Venous thrombosis	0.00% 0/25 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/24 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	4.5% 1/22 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.	0.00% 0/20 • Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 8 weeks post treatment, up to maximum duration of 56 weeks. Any sign or symptom collected in the double-blinded period i.e 24 weeks followed by an additional 24-week open label phase (optional). Adverse events were reported separately for the double-blind and the open-label phase.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

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 (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER