Trial Outcomes & Findings for A 6 Month Safety Extension Study of MBGS205 (NCT NCT02908074)

Last Updated: 2023-05-18

Results Overview

Percentage change in lumbar bone mineral density measured by DEXA (g/cm\^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206 by dose group in participants randomised to active treatment in MBGS205.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

143 participants

Primary outcome timeframe

At 48 weeks compared to baseline in MBGS205

Results posted on

2023-05-18

Participant Flow

Participants receiving active doses of BGS649 in Study MBGS205 continued with the same dose in Study MBGS206; Participants receiving placebo in Study MBGS205 were re-randomised at the Baseline visit to receive one of the 3 treatment regimens (BGS649 0.1 mg, 0.3 mg, and 1.0 mg) in a 1:1:1 ratio, and were only assessed for safety in study MBGS206.

Participant milestones

Participant milestones
Measure	BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Overall Study STARTED	38	33	31	13	17	11
Overall Study Received at Least 1 Dose of Study Drug	38	33	30	13	17	10
Overall Study Safety Population	38	33	30	13	17	10
Overall Study Intention-to-treat (ITT) Population	38	33	30	0	0	0
Overall Study COMPLETED	29	27	25	10	13	7
Overall Study NOT COMPLETED	9	6	6	3	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Overall Study sponsor/ICON decision	0	0	1	0	0	0
Overall Study Protocol Violation	0	1	0	0	0	0
Overall Study Adverse Event	5	2	0	0	1	0
Overall Study AESI	1	0	1	0	1	0
Overall Study Discontinuation criteria per protocol	0	0	1	0	0	1
Overall Study Withdrawal by Subject	3	2	2	2	2	2
Overall Study Lost to Follow-up	0	1	1	1	0	1

Baseline Characteristics

A 6 Month Safety Extension Study of MBGS205

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BGS649 0.1 mg n=38 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=33 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=30 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.1 mg n=13 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=10 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Total n=141 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 7.34 • n=5 Participants	51.9 years STANDARD_DEVIATION 7.76 • n=7 Participants	50.0 years STANDARD_DEVIATION 9.98 • n=5 Participants	48.9 years STANDARD_DEVIATION 11.04 • n=4 Participants	49.8 years STANDARD_DEVIATION 8.93 • n=21 Participants	51.1 years STANDARD_DEVIATION 8.32 • n=10 Participants	51.0 years STANDARD_DEVIATION 8.60 • n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	33 Participants n=7 Participants	30 Participants n=5 Participants	13 Participants n=4 Participants	17 Participants n=21 Participants	10 Participants n=10 Participants	141 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	29 Participants n=115 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	23 Participants n=7 Participants	19 Participants n=5 Participants	11 Participants n=4 Participants	15 Participants n=21 Participants	8 Participants n=10 Participants	106 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants

PRIMARY outcome

Timeframe: At 48 weeks compared to baseline in MBGS205

Population: The Intention-to-treat (ITT) population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine bone mineral density (BMD) measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=21 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=16 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=16 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Percent Change in Bone Mineral Density Measured by DEXA (g/cm^2) From Baseline in Study MBGS205 to Week 48 in Study MBGS206	-2.24 Percentage change Standard Deviation 3.157	-3.31 Percentage change Standard Deviation 5.301	-1.68 Percentage change Standard Deviation 3.095	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Population: The ITT population included all participants who: were randomised, and received at least 1 dose of study medication, and provided a Baseline lumbar spine BMD measure in MBGS205 and at least one available evaluation of lumbar spine post-Baseline in MBGS206. Here, the "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Percentage change from baseline in hip (total and femoral neck) bone mineral density measured by DEXA (g/cm\^2) from Baseline in Study MBGS205 to Week 48 in Study MBGS206

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=24 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=17 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read) Bone Density (Hip)	0.01 percentage of change Standard Deviation 3.407	-1.71 percentage of change Standard Deviation 3.590	0.61 percentage of change Standard Deviation 4.304	—	—	—
Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read) Bone Density (Femoral Neck)	-1.09 percentage of change Standard Deviation 5.205	-2.60 percentage of change Standard Deviation 6.899	-0.15 percentage of change Standard Deviation 5.155	—	—	—
Percentage Change From Baseline in DEXA Scan Density (g/cm^2) by Location for Subjects Randomised to Active Treatment in Study MBGS205 (Over-read) Bone Density (Lumbar Spine)	-1.94 percentage of change Standard Deviation 3.378	-3.31 percentage of change Standard Deviation 5.301	-1.99 percentage of change Standard Deviation 3.159	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Percentage change from baseline in bone turnover markers (C-terminal telopeptide \[CTx1\], osteocalcin, bone alkaline phosphatase, and procollagen type 1 N-propeptide \[P1NP\]) from Baseline in Study MBGS205 to Week 48 in Study MBGS206

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=28 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=26 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=23 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205 2Type I Collagen C-Telopeptides	83.28 ug/L Standard Deviation 164.647	64.42 ug/L Standard Deviation 64.473	57.91 ug/L Standard Deviation 82.289	—	—	—
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205 Procollagen 1 N-Terminal Propeptide	40.40 ug/L Standard Deviation 32.108	37.62 ug/L Standard Deviation 44.742	34.17 ug/L Standard Deviation 35.017	—	—	—
Descriptive Summary of Percentage Change in Bone Turnover Markers for Subjects Randomised to Active Treatment in Study MBGS205 Osteocalcin	13.79 ug/L Standard Deviation 17.525	18.86 ug/L Standard Deviation 28.545	15.28 ug/L Standard Deviation 25.980	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Proportion of subjects with DEXA scan T- scores ≤ -2.5 at Week 48 in MBGS206 compared to baseline in MBGS205 by body location (using overread scan images).

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=24 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=16 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg n=8 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=13 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=4 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location T - Score (Hip) ≤ -2.5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location T - Score (Femoral Neck) ≤ -2.5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Percentage of Subjects With DEXA Scan T-score ≤ -2.5 at Week 48 by Location T - Score (Lumbar Spine) ≤ -2.5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 Weeks

Percentage change from baseline in bone density and bone biomarkers for vitamin D deficiency from Baseline in Study MBGS205 to Week 48 in Study MBGS206. Bone mineral density (g/cm\^2) measured by DEXA over-read by a central reader.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=17 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=13 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=14 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg n=6 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=8 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=2 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency Bone Density (Femoral Neck) (g/cm2)	-1.93 percentage change from baseline in DEXA Standard Deviation 5.743	-2.27 percentage change from baseline in DEXA Standard Deviation 6.739	0.19 percentage change from baseline in DEXA Standard Deviation 5.161	-0.56 percentage change from baseline in DEXA Standard Deviation 4.485	0.16 percentage change from baseline in DEXA Standard Deviation 2.640	3.02 percentage change from baseline in DEXA Standard Deviation NA SD not calculable for single participant
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency Bone Density (Lumbar Spine) (g/cm2)	-2.10 percentage change from baseline in DEXA Standard Deviation 3.623	-3.86 percentage change from baseline in DEXA Standard Deviation 5.966	-2.01 percentage change from baseline in DEXA Standard Deviation 3.520	1.54 percentage change from baseline in DEXA Standard Deviation 4.463	-0.08 percentage change from baseline in DEXA Standard Deviation 2.017	-3.12 percentage change from baseline in DEXA Standard Deviation 1.691
Percentage Change From Baseline in Bone Mineral Density by Location and Vitamin D Deficiency Bone Density (Hip) (g/cm2)	-0.86 percentage change from baseline in DEXA Standard Deviation 3.129	-1.81 percentage change from baseline in DEXA Standard Deviation 3.684	1.22 percentage change from baseline in DEXA Standard Deviation 4.532	-0.78 percentage change from baseline in DEXA Standard Deviation 3.910	0.09 percentage change from baseline in DEXA Standard Deviation 1.497	4.36 percentage change from baseline in DEXA Standard Deviation NA SD not calculable for single participant

SECONDARY outcome

Timeframe: 48 Weeks

Descriptive Summary of Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=28 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=27 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=24 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline of Oestradiol (Absolute) From Baseline in Study MBGS205 to Week 48	-12.750 Oestradiol (pg/mL) Standard Deviation 13.4264	-11.852 Oestradiol (pg/mL) Standard Deviation 5.6820	-12.917 Oestradiol (pg/mL) Standard Deviation 9.0117	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Descriptive Summary of Percentage Change in Oestradiol and Testosterone/Oestradiol Ratio for Subjects Randomised to Active Treatment in Study MBGS205

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=28 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=27 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=24 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline of Oestradiol (Percentage) From Baseline in Study MBGS205 to Week 48	-39.54 percentage from baseline at Week 48 Standard Deviation 33.295	-47.00 percentage from baseline at Week 48 Standard Deviation 17.852	-48.30 percentage from baseline at Week 48 Standard Deviation 19.752	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Proportion of subjects that overshoot testosterone (total testosterone above 1000 ng/dl \[35 nmol/L\], from first dose of study drug in Study MBGS205 until study completion)

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=25 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=21 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Analysis of Proportion of Subjects That Overshoot Testosterone for Subjects Randomised to Active Treatment in Study MBGS205	0 Participants	0 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Summary of Laboratory Test Results and Change from Baseline: PSA for Subjects Randomised to Active Treatment in Study MBGS205

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=28 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=27 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=24 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline in PSA From Baseline in Study MBGS205 to Week 48 in Study MBGS206	0.163 Prostate Specific Antigen (ug/L) Standard Deviation 0.2454	0.164 Prostate Specific Antigen (ug/L) Standard Deviation 0.6410	0.169 Prostate Specific Antigen (ug/L) Standard Deviation 0.6246	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Change from baseline in haematocrit from Baseline in Study MBGS205 to Week 48 in Study MBGS206

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=28 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=27 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=24 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline in Haematocrit at Week 48	0.0128 RATIO (Change) Standard Deviation 0.02273	0.0136 RATIO (Change) Standard Deviation 0.02517	0.0286 RATIO (Change) Standard Deviation 0.03410	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Change from baseline in blood pressure (systolic and diastolic measured in mmHg) Baseline in Study MBGS205 to Week 48 in Study MBGS206.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=20 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=19 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205 Systolic Blood Pressure	2.7 Blood Pressure (mmHg) (Change) Standard Deviation 7.13	2.6 Blood Pressure (mmHg) (Change) Standard Deviation 12.64	-0.7 Blood Pressure (mmHg) (Change) Standard Deviation 8.34	—	—	—
Change From Baseline in Blood Pressure From Baseline to Week 48MBGS205 Diastolic Blood Pressure	-0.2 Blood Pressure (mmHg) (Change) Standard Deviation 8.12	1.1 Blood Pressure (mmHg) (Change) Standard Deviation 4.41	1.6 Blood Pressure (mmHg) (Change) Standard Deviation 8.30	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Percentage of subjects where bioavailable testosterone was normalised at week 48 in Study MBGS206. Where normalisation was considered testosterone in the range 300-1000 mg/dL.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=25 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=21 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg n=8 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=11 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=5 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Percentage of Subjects Achieving Normalisation of Bioavailable (Total) Testosterone at Wk 48	25 Participants	17 Participants	19 Participants	6 Participants	11 Participants	5 Participants

SECONDARY outcome

Timeframe: 48 Weeks

Change from baseline in total, free and bioavailable testosterone from Baseline in Study MBGS205 to Week 48 in Study MBGS206

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=20 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=16 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=17 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Descriptive Summary of Total Testosterone (ng/dL) for Subjects Randomised to Active Treatment in Study MBGS205	241.0 Total Testosterone (ng/dL) Change Standard Deviation 99.14	290.6 Total Testosterone (ng/dL) Change Standard Deviation 109.64	378.9 Total Testosterone (ng/dL) Change Standard Deviation 158.67	—	—	—

SECONDARY outcome

Timeframe: 48 Weeks

Change from baseline in free and bioavailable (total) testosterone from baseline in Study MBGS205 to Week 48 in Study MBGS206.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=20 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=16 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=17 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg n=7 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=11 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=3 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline in Free and Bioavailable Testosterone Bioavailable Testosterone (ng/dL)	162.12 (ng/dL) and (ng/L), respectively Standard Deviation 70.686	191.23 (ng/dL) and (ng/L), respectively Standard Deviation 76.431	255.57 (ng/dL) and (ng/L), respectively Standard Deviation 103.758	168.71 (ng/dL) and (ng/L), respectively Standard Deviation 111.634	240.25 (ng/dL) and (ng/L), respectively Standard Deviation 111.842	255.27 (ng/dL) and (ng/L), respectively Standard Deviation 111.674
Change From Baseline in Free and Bioavailable Testosterone Testosterone, Free (ng/L)	60.28 (ng/dL) and (ng/L), respectively Standard Deviation 25.020	72.65 (ng/dL) and (ng/L), respectively Standard Deviation 26.674	94.82 (ng/dL) and (ng/L), respectively Standard Deviation 35.674	61.01 (ng/dL) and (ng/L), respectively Standard Deviation 40.632	84.62 (ng/dL) and (ng/L), respectively Standard Deviation 38.353	90.47 (ng/dL) and (ng/L), respectively Standard Deviation 37.064

SECONDARY outcome

Timeframe: 48 Weeks

Change from baseline of LH from Baseline in Study MBGS205 to Week 48 in Study MBGS206.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=20 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=19 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg n=7 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=11 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=3 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline in Luteinizing Hormone From Baseline to Week 48	2.683 Luteinizing Hormone (mIU/mL) Standard Deviation 1.6586	3.665 Luteinizing Hormone (mIU/mL) Standard Deviation 2.3477	3.613 Luteinizing Hormone (mIU/mL) Standard Deviation 2.7807	3.973 Luteinizing Hormone (mIU/mL) Standard Deviation 4.1420	4.834 Luteinizing Hormone (mIU/mL) Standard Deviation 3.1930	2.720 Luteinizing Hormone (mIU/mL) Standard Deviation 0.5071

SECONDARY outcome

Timeframe: 48 Weeks

Change from Baseline in Study MBGS205 to Week 48 in Study MBGS206 in follicle stimulating hormone (FSH).

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=20 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=17 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=19 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline in Follicle Stimulating Hormone at Week 48	5.473 Follicle Stimulating Hormone (mIU/mL) Standard Deviation 2.9494	7.509 Follicle Stimulating Hormone (mIU/mL) Standard Deviation 3.0235	6.781 Follicle Stimulating Hormone (mIU/mL) Standard Deviation 5.2389	—	—	—

SECONDARY outcome

Timeframe: 48 weeks

Percentage change in baseline in alkaline phosphatase from baseline in study MBGS205 to week 48 in MBGS206.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=28 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 0.3 mg n=26 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	BGS649 1.0 mg n=23 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks in MBGS205 and 24 weeks in MBGS206	Placebo to BGS649 0.1 mg n=10 Participants Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=13 Participants Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=6 Participants Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Percentage Change in Bone Alkaline Phosphatase	12.67 U/L Standard Deviation 16.025	3.85 U/L Standard Deviation 17.856	15.28 U/L Standard Deviation 5.82	14.46 U/L Standard Deviation 22.493	-3.40 U/L Standard Deviation 16.672	3.80 U/L Standard Deviation 13.025

Adverse Events

BGS649 0.1 mg

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

BGS649 0.3 mg

Serious events: 2 serious events

Other events: 23 other events

Deaths: 1 deaths

BGS649 1.0 mg

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo to BGS649 0.1 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo to BGS649 0.3 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo to BGS649 1.0 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BGS649 0.1 mg n=38 participants at risk Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=33 participants at risk Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=30 participants at risk Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.1 mg n=13 participants at risk Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=17 participants at risk Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=10 participants at risk Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Gastrointestinal disorders Faecaloma	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Chest pain	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.

Other adverse events

Other adverse events
Measure	BGS649 0.1 mg n=38 participants at risk Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=33 participants at risk Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=30 participants at risk Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.1 mg n=13 participants at risk Drug: BGS649 Dose 1 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 0.3 mg n=17 participants at risk Drug: BGS649 Dose 2 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo to BGS649 1.0 mg n=10 participants at risk Drug: BGS649 Dose 3 weekly BGS649: Capsules will be taken weekly for a maximum of 24 weeks
Musculoskeletal and connective tissue disorders Osteoarthritis	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Upper respiratory tract infection	7.9% 3/38 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	13.3% 4/30 • Number of events 5 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	15.4% 2/13 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	29.4% 5/17 • Number of events 6 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Nasopharyngitis	2.6% 1/38 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	9.1% 3/33 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Influenza	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Urinary tract infection	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Furuncle	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Pneumonia	5.3% 2/38 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Tooth infection	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Viral infection	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Bronchitis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Cellulitis	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Ear infection	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Folliculitis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Fungal infection	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Gastritis viral	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Gastroenteritis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Lower respiratory tract infection	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Paronychia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Rash pustular	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Respiratory tract infection	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Sinusitis	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Subcutaneous abscess	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Infections and infestations Tooth abscess	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Prostatic specific antigen increased	13.2% 5/38 • Number of events 6 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	11.8% 2/17 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Haematocrit increased	7.9% 3/38 • Number of events 6 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Blood triglycerides increased	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	15.4% 2/13 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Weight increased	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Blood creatinine increased	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Blood pressure increased	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Blood urine present	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations C-reactive protein increased	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Glycosylated haemoglobin increased	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Alanine aminotransferase increased	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Antinuclear antibody positive	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Electrocardiogram abnormal	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Liver function test increased	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Investigations Red blood cells urine positive	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 4/38 • Number of events 4 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Back pain	5.3% 2/38 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	5.3% 2/38 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Tendon pain	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Oedema peripheral	5.3% 2/38 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Fatigue	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	9.1% 3/33 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Influenza like illness	7.9% 3/38 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Oedema	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Pyrexia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Chest pain	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Feeling hot	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
General disorders Peripheral swelling	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Diarrhoea	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Abdominal discomfort	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Dry mouth	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Abdominal pain	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Constipation	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Haemorrhoids	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Umbilical hernia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Gastrointestinal disorders Vomiting	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Gynaecomastia	5.3% 2/38 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	9.1% 3/33 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Breast enlargement	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Erectile dysfunction	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Testicular hypertrophy	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Testicular pain	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Breast mass	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Penis disorder	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Reproductive system and breast disorders Spontaneous penile erection	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Headache	13.2% 5/38 • Number of events 7 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Dizziness	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Lethargy	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Paraesthesia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Presyncope	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Restless legs syndrome	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Sciatica	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Syncope	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Thoracic outlet syndrome	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Nervous system disorders Tremor	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Ligament sprain	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Bone contusion	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Fascial rupture	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Joint injury	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Laceration	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Limb injury	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Meniscus injury	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Muscle strain	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Injury, poisoning and procedural complications Spinal compression fracture	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.3% 2/38 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	11.8% 2/17 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Diabetes mellitus	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Increased appetite	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Dehydration	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Hypercholesterolaemia	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Hypokalaemia	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 3/30 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Dermatitis	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	15.4% 2/13 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Psychiatric disorders Depression	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Psychiatric disorders Insomnia	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Psychiatric disorders Libido decreased	5.3% 2/38 • Number of events 3 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Psychiatric disorders Apathy	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Psychiatric disorders Mood altered	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Psychiatric disorders Sleep disorder	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	5.9% 1/17 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Blood and lymphatic system disorders Polycythaemia	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Renal and urinary disorders Dysuria	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Renal and urinary disorders Haematuria	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Renal and urinary disorders Nocturia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Renal and urinary disorders Pollakiuria	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Renal and urinary disorders Renal cyst	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Vascular disorders Hypertension	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.7% 2/30 • Number of events 4 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Vascular disorders Hot flush	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Eye disorders Eye haemorrhage	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Eye disorders Glaucoma	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Eye disorders Lacrimation increased	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Ear and labyrinth disorders Tinnitus	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	7.7% 1/13 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	10.0% 1/10 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Immune system disorders Hypersensitivity	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Immune system disorders Seasonal allergy	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.0% 1/33 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Endocrine disorders Hyperadrenalism	2.6% 1/38 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/38 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	6.1% 2/33 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/30 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.
Musculoskeletal and connective tissue disorders Trigger finger	2.6% 1/38 • Number of events 2 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/33 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	3.3% 1/30 • Number of events 1 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/13 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/17 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.	0.00% 0/10 • Overall Adverse Events During the Active Treatment Period and Follow-up (48 Week Treatment Period plus 12 Weeks follow-up) The safety population included all participants who received at least 1 administration of the study medication.

Additional Information

Jackie Parkin

Mereo BioPharma Group

Phone: +44 (0) 333 023 7300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place