Trial Outcomes & Findings for Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia (NCT NCT01266876)

NCT ID: NCT01266876

Last Updated: 2015-09-22

Results Overview

Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward \[LOCF\] method.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 77 participants
• Primary outcome timeframe: From Baseline to Week 12 (LOCF)
• Results posted on: 2015-09-22

Participant Flow

The study was conducted at 16 centers in the United States of America and Canada. Overall, 118 participants were screened between January 2011 and June 2011.

Randomization was stratified by concomitant use of ezetimibe (Yes/No). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1 ratio after confirmation of selection criteria. 77 participants were randomized.

Participant milestones

Measure	Placebo Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Study STARTED	15	15	16	15	16
Overall Study COMPLETED	15	15	16	14	16
Overall Study NOT COMPLETED	0	0	0	1	0

Reasons for withdrawal

Measure	Placebo Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Study Adverse Event	0	0	0	1	0

Baseline Characteristics

Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia

Baseline characteristics by cohort

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Total n=77 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	51.3 years STANDARD_DEVIATION 7.7 • n=7 Participants	52.9 years STANDARD_DEVIATION 11.2 • n=5 Participants	54.3 years STANDARD_DEVIATION 9.6 • n=4 Participants	56.3 years STANDARD_DEVIATION 10.2 • n=21 Participants	53.4 years STANDARD_DEVIATION 9.7 • n=10 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	30 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	13 Participants n=21 Participants	47 Participants n=10 Participants
Low Density Lipoprotein Cholesterol (LDL-C) in mg/dL	150.8 mg/dL STANDARD_DEVIATION 34.0 • n=5 Participants	166.7 mg/dL STANDARD_DEVIATION 50.1 • n=7 Participants	169.8 mg/dL STANDARD_DEVIATION 57.0 • n=5 Participants	139.6 mg/dL STANDARD_DEVIATION 24.7 • n=4 Participants	147.2 mg/dL STANDARD_DEVIATION 32.6 • n=21 Participants	154.9 mg/dL STANDARD_DEVIATION 42.1 • n=10 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.

Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis	-10.7 percent change Standard Error 5.0	-28.9 percent change Standard Error 5.1	-31.5 percent change Standard Error 4.9	-42.5 percent change Standard Error 5.1	-67.9 percent change Standard Error 4.9

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.

Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis	-19.1 mg/dL Standard Error 7.9	-42.2 mg/dL Standard Error 8.0	-51.3 mg/dL Standard Error 7.7	-66.9 mg/dL Standard Error 8.0	-102.5 mg/dL Standard Error 7.6

SECONDARY outcome

Timeframe: Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.

Calculated LDL-C value was obtained from Friedewald formula.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis	13.3 percentage of participants	26.7 percentage of participants	18.8 percentage of participants	66.7 percentage of participants	93.8 percentage of participants

SECONDARY outcome

Timeframe: Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.

Calculated LDL-C value was obtained from Friedewald formula.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis	0.0 percentage of participants	13.3 percentage of participants	12.5 percentage of participants	46.7 percentage of participants	81.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one on-treatment total cholesterol value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis	-8.5 percent change Standard Error 3.8	-18.1 percent change Standard Error 3.9	-19.7 percent change Standard Error 3.7	-25.7 percent change Standard Error 3.8	-43.6 percent change Standard Error 3.7

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment total cholesterol value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis	-20.3 mg/dL Standard Error 9.4	-40.3 mg/dL Standard Error 9.5	-50.1 mg/dL Standard Error 9.2	-61.7 mg/dL Standard Error 9.5	-99.9 mg/dL Standard Error 9.1

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one on-treatment HDL-C value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint..

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis	2.2 percent change Standard Error 3.7	7.9 percent change Standard Error 3.7	6.5 percent change Standard Error 3.5	1.00 percent change Standard Error 3.8	12.3 percent change Standard Error 3.6

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline HDL-C value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis	0.4 mg/dL Standard Error 1.9	4.2 mg/dL Standard Error 1.9	3.3 mg/dL Standard Error 1.8	4.5 mg/dL Standard Error 2.0	6.0 mg/dL Standard Error 1.8

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis	-10.6 percent change Interval -28.5 to 9.5	-16.7 percent change Interval -30.1 to 21.1	-13.2 percent change Interval -30.9 to 7.4	-4.9 percent change Interval -17.0 to 10.3	-16.2 percent change Interval -30.7 to 25.1

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis	-11.0 mg/dL Interval -89.5 to 7.5	-20.0 mg/dL Interval -37.0 to 13.0	-13.5 mg/dL Interval -35.3 to 9.5	-3.5 mg/dL Interval -33.0 to 6.0	-14.8 mg/dL Interval -64.5 to 34.0

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis	-11.3 percent change Standard Error 4.7	-26.8 percent change Standard Error 4.8	-27.4 percent change Standard Error 4.6	-39.0 percent change Standard Error 4.8	-57.9 percent change Standard Error 4.6

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis	-22.8 mg/dL Standard Error 8.8	-46.0 mg/dL Standard Error 8.9	-52.3 mg/dL Standard Error 8.6	-70.6 mg/dL Standard Error 9.0	-103.6 mg/dL Standard Error 8.5

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis	-6.4 percent change Standard Error 4.2	-20.9 percent change Standard Error 4.2	-20.9 percent change Standard Error 4.0	-28.4 percent change Standard Error 4.3	-50.2 percent change Standard Error 4.0

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis	-9.3 mg/dL Standard Error 5.5	-24.3 mg/dL Standard Error 5.5	-28.7 mg/dL Standard Error 5.3	-34.7 mg/dL Standard Error 5.6	-64.4 mg/dL Standard Error 5.3

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis	-5.3 percent change Standard Error 3.1	2.4 percent change Standard Error 3.1	1.7 percent change Standard Error 2.9	5.6 percent change Standard Error 3.1	8.8 percent change Standard Error 2.9

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis	-9.7 mg/dL Standard Error 4.6	3.4 mg/dL Standard Error 4.5	2.8 mg/dL Standard Error 4.3	7.8 mg/dL Standard Error 4.6	11.0 mg/dL Standard Error 4.4

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B and ApoA-1 value.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis	-0.03 ratio Standard Error 0.04	-0.18 ratio Standard Error 0.04	-0.20 ratio Standard Error 0.04	-0.25 ratio Standard Error 0.04	-0.49 ratio Standard Error 0.04

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis	-3.9 percent change Interval -18.4 to 0.0	-10.1 percent change Interval -22.2 to 3.8	-7.5 percent change Interval -22.5 to 0.0	-15.3 percent change Interval -25.2 to 10.6	-23.4 percent change Interval -44.6 to -6.6

SECONDARY outcome

Timeframe: From Baseline to Week 12 (LOCF)

Population: mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)

Outcome measures

Measure	Placebo n=15 Participants Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 Participants Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 Participants Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 Participants Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 Participants Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis	-2.0 mg/dL Interval -7.0 to 0.0	-1.5 mg/dL Interval -10.0 to 1.5	-1.8 mg/dL Interval -5.0 to 0.0	-8.0 mg/dL Interval -19.0 to 5.0	-11.5 mg/dL Interval -26.0 to 1.8

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Alirocumab 150 mg Q4W

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Alirocumab 200 mg Q4W

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Alirocumab 300 mg Q4W

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Alirocumab 150 mg Q2W

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=15 participants at risk Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 participants at risk Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 participants at risk Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 participants at risk Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 participants at risk Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Gastrointestinal disorders Intestinal obstruction	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.

Other adverse events

Measure	Placebo n=15 participants at risk Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q4W n=15 participants at risk Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 200 mg Q4W n=16 participants at risk Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 300 mg Q4W n=15 participants at risk Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.	Alirocumab 150 mg Q2W n=16 participants at risk Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
General disorders Injection site urticaria	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site vesicles	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Oedema peripheral	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Pyrexia	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Bronchitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Diverticulitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Fungal skin infection	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Non-Cardiac chest pain	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Blood and lymphatic system disorders Anaemia	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Ear and labyrinth disorders Cerumen impaction	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Ear and labyrinth disorders Tinnitus	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Eye disorders Conjunctivitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Eye disorders Ocular icterus	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Abdominal distension	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Constipation	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	20.0% 3/15 • Number of events 4 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	18.8% 3/16 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Flatulence	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Gastritis erosive	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Gingivitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Gingivitis ulcerative	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Haematochezia	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Haemorrhoids	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Intestinal obstruction	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Nausea	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	12.5% 2/16 • Number of events 4 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Gastrointestinal disorders Toothache	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Chest discomfort	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Chills	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Fatigue	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Feeling hot	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Influenza like illness	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site discolouration	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site dryness	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site erythema	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	25.0% 4/16 • Number of events 6 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	26.7% 4/15 • Number of events 12 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site exfoliation	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site haematoma	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	20.0% 3/15 • Number of events 4 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site haemorrhage	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	12.5% 2/16 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	12.5% 2/16 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site oedema	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site pain	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	12.5% 2/16 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site paraesthesia	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site pruritus	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	20.0% 3/15 • Number of events 6 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site rash	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	12.5% 2/16 • Number of events 5 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site reaction	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
General disorders Injection site swelling	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Gastroenteritis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Infected bites	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Influenza	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Nasopharyngitis	13.3% 2/15 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	12.5% 2/16 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Oral herpes	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Pharyngitis streptococcal	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Pneumonia	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Prostate infection	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Rhinitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Sinusitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Upper respiratory tract infection	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Urinary tract infection	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Infections and infestations Vaginal infection	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Concussion	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Epicondylitis	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Laceration	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Limb injury	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Investigations Bacterial test positive	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Investigations Blood pressure increased	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Investigations Blood pressure systolic decreased	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Investigations Cardiac murmur	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Investigations Thyroxine decreased	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Investigations Urinary sediment present	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Investigations White blood cell count decreased	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Nervous system disorders Dizziness	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Nervous system disorders Dizziness postural	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Nervous system disorders Headache	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	12.5% 2/16 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Nervous system disorders Migraine	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Nervous system disorders Migraine with aura	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Nervous system disorders Sciatica	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Psychiatric disorders Depression	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Psychiatric disorders Disorientation	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Psychiatric disorders Panic attack	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Renal and urinary disorders Calculus urinary	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Renal and urinary disorders Dysuria	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Renal and urinary disorders Haematuria	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Renal and urinary disorders Micturition urgency	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Reproductive system and breast disorders Haematospermia	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	13.3% 2/15 • Number of events 3 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Skin and subcutaneous tissue disorders Rash	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.7% 1/15 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Vascular disorders Flushing	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
Vascular disorders Hypertension	13.3% 2/15 • Number of events 2 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/16 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	0.00% 0/15 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.	6.2% 1/16 • Number of events 1 • From Baseline up to Week 12 Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.

Additional Information

Clinical Trial Management

Regeneron Pharmaceuticals, Inc

Email: clinicaltrials@regeneron.com

Results disclosure agreements

• Principal investigator is a sponsor employee Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
• Publication restrictions are in place

Restriction type: OTHER