Trial Outcomes & Findings for Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (NCT NCT02763046)

NCT ID: NCT02763046

Last Updated: 2021-10-08

Results Overview

ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response is defined as an improvement from baseline of ≥20% and ≥1 unit on a scale of 0-10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 0-10 in the remaining domain. The four main ASAS domains are: Patient's global assessment of disease activity, back pain, function represented by ability to perform specific tasks (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]) and inflammation represented by mean duration and severity of morning stiffness. Non-responder imputation was applied for missing data.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 211 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2021-10-08

Participant Flow

Participants took part in 40 investigative sites in Germany.

Participants were randomized 1:1:1 to one of the following treatment groups: secukinumab 150 mg s.c. with delayed NSAID tapering, secukinumab 150 mg s.c. with early NSAID tapering and placebo.

Participant milestones

Measure	Secukinumab - Delayed NSAID Tapering Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering).	Secukinumab - Early NSAID Tapering Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering).	Placebo Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.
Overall Study STARTED	71	70	70
Overall Study COMPLETED	62	65	62
Overall Study NOT COMPLETED	9	5	8

Reasons for withdrawal

Measure	Secukinumab - Delayed NSAID Tapering Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering).	Secukinumab - Early NSAID Tapering Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering).	Placebo Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.
Overall Study Adverse Event	5	4	0
Overall Study Lack of Efficacy	1	1	3
Overall Study Physician Decision	1	0	1
Overall Study Subject/guardian decision	2	0	4

Baseline Characteristics

Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis

Baseline characteristics by cohort

Measure	Secukinumab - Delayed NSAID Tapering n=71 Participants Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering).	Secukinumab - Early NSAID Tapering n=70 Participants Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering).	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Total n=211 Participants Total of all reporting groups
Age, Continuous	46.2 Years STANDARD_DEVIATION 13.36 • n=5 Participants	44.1 Years STANDARD_DEVIATION 11.02 • n=7 Participants	45.4 Years STANDARD_DEVIATION 12.55 • n=5 Participants	45.2 Years STANDARD_DEVIATION 12.32 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	28 Participants n=7 Participants	31 Participants n=5 Participants	89 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	42 Participants n=7 Participants	39 Participants n=5 Participants	122 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	69 Participants n=5 Participants	67 Participants n=7 Participants	68 Participants n=5 Participants	204 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set (FAS) comprising all subjects from the randomized set to whom study treatment was assigned.

ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response is defined as an improvement from baseline of ≥20% and ≥1 unit on a scale of 0-10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 0-10 in the remaining domain. The four main ASAS domains are: Patient's global assessment of disease activity, back pain, function represented by ability to perform specific tasks (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]) and inflammation represented by mean duration and severity of morning stiffness.

Non-responder imputation was applied for missing data.

Outcome measures

Measure	Secukinumab - Pooled n=141 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Placebo Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Secukinumab - Pooled The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
Proportion of Patients Who Achieved ASAS20 Response in the Pooled Secukinumab Group Compared With the Placebo Group at Week 12	72 Participants	31 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 16

Population: FAS comprising all subjects from the randomized set to whom study treatment was assigned.

ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response is defined as an improvement from baseline of ≥20% and ≥1 unit on a scale of 0-10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 0-10 in the remaining domain. The four main ASAS domains are: Patient's global assessment of disease activity, back pain, function represented by ability to perform specific tasks (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]) and inflammation represented by mean duration and severity of morning stiffness.

Non-responder imputation was applied for missing data.

Outcome measures

Measure	Secukinumab - Pooled n=71 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Secukinumab - Pooled The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
Proportion of Patients Who Achieved ASAS20 Response in Each Secukinumab Group (Delayed NSAID Tapering and Early NSAID Tapering) Compared With the Placebo Group Week 12	37 Participants	35 Participants	31 Participants	—
Proportion of Patients Who Achieved ASAS20 Response in Each Secukinumab Group (Delayed NSAID Tapering and Early NSAID Tapering) Compared With the Placebo Group Week 16	40 Participants	35 Participants	29 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS comprising all subjects from the randomized set to whom study treatment was assigned.

ASAS-NSAID score is used to present the NSAID (nonsteroidal anti-inflammatory drug) intake by considering the type of NSAID, the total dose and the number of days taking NSAID during a period of interest (PI). For the NSAID equivalence scoring system, "no NSAID intake" was set to a score value of 0, and the reference dose of 150 mg/day diclofenac was set to a score value of 100. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac. ASAS-NSAID score = (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).

A negative change from baseline indicates less NSAID consumption.

Outcome measures

Measure	Secukinumab - Pooled n=71 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Secukinumab - Pooled n=141 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
Mean Change From Baseline in ASAS-NSAID Score at Week 12	-44.9 Score on scale Standard Deviation 47.32	-40.3 Score on scale Standard Deviation 71.48	-31.5 Score on scale Standard Deviation 36.54	-42.6 Score on scale Standard Deviation 60.53

SECONDARY outcome

Timeframe: Baseline, Week 12 (delayed NSAID tapering), Week 16 (early NSAID tapering)

Population: FAS comprising all subjects from the randomized set to whom study treatment was assigned.

ASAS-NSAID score is used to present the NSAID (nonsteroidal anti-inflammatory drug) intake by considering the type of NSAID, the total dose and the number of days taking NSAID during a period of interest (PI). For the NSAID equivalence scoring system, "no NSAID intake" was set to a score value of 0, and the reference dose of 150 mg/day diclofenac was set to a score value of 100. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac. ASAS-NSAID score = (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).

A negative change from baseline indicates less NSAID consumption. For this endpoint the analysis was performed after 12 weeks of exposure to secukinumab which was achieved at Week 12 in the secukinumab delayed NSAID tapering group but at Week 16 in the secukinumab early NSAID tapering group.

Outcome measures

Measure	Secukinumab - Pooled n=71 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Placebo Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Secukinumab - Pooled The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
Mean Change From Baseline in ASAS-NSAID Score in Each Secukinumab Group After 12 Weeks of Exposure (at Week 12 in the Secukinumab-delayed NSAID Tapering Group and at Week 16 in the Secukinumab-early NSAID Tapering Group)	-44.9 Score on scale Standard Deviation 47.32	-42.5 Score on scale Standard Deviation 68.62	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 16

Population: FAS comprising all subjects from the randomized set to whom study treatment was assigned.

The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to ankylosing spondylitis: 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (captured as a continuous visual analog scale). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe symptoms.

A negative change from baseline in the total 0-10 BASDAI score indicates improvement.

Outcome measures

Measure	Secukinumab - Pooled n=71 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Secukinumab - Pooled n=141 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
Mean Change From Baseline in the BASDAI Total Score Week 16	-2.3 Score on scale Standard Deviation 1.90	-2.0 Score on scale Standard Deviation 1.96	-1.7 Score on scale Standard Deviation 1.96	-2.2 Score on scale Standard Deviation 1.93
Mean Change From Baseline in the BASDAI Total Score Week 12	-2.1 Score on scale Standard Deviation 2.16	-2.0 Score on scale Standard Deviation 2.10	-1.8 Score on scale Standard Deviation 2.00	-2.1 Score on scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS comprising all subjects from the randomized set to whom study treatment was assigned.

The Short Form-36 Health Survey (SF-36) measures the impact of disease on overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36 (SF-36 PCS) that is evaluated in this study. Scores on each item 1-4 were summed and averaged (range = 0-100 with higher scores indicating better levels of function and/or better health). A positive change from Baseline indicates improvement.

Outcome measures

Measure	Secukinumab - Pooled n=71 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Placebo n=70 Participants Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.	Secukinumab - Pooled n=141 Participants The 2 secukinumab arms (delayed NSAID tapering and early NSAID tapering) pooled.
Mean Change From Baseline in Health-related Quality of Life as Measured by the Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score	4.8 Score on scale Standard Deviation 7.03	6.1 Score on scale Standard Deviation 6.92	4.8 Score on scale Standard Deviation 7.43	5.5 Score on scale Standard Deviation 6.98

Adverse Events

Secukinumab - Delayed NSAID Tapering - Treatment Period 1

Serious events: 4 serious events

Other events: 53 other events

Deaths: 0 deaths

Secukinumab - Early NSAID Tapering - Treatment Period 1

Serious events: 3 serious events

Other events: 56 other events

Deaths: 0 deaths

Placebo - Treatment Period 1

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Secukinumab - Delayed NSAID Tapering - Treatment Period 2

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Secukinumab - Early NSAID Tapering - Treatment Period 2

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo - Treatment Period 2

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Secukinumab - Delayed NSAID Tapering - Treatment Period 1 n=71 participants at risk Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering). Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study.	Secukinumab - Early NSAID Tapering - Treatment Period 1 n=70 participants at risk Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering). Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study.	Placebo - Treatment Period 1 n=70 participants at risk Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4. Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study.	Secukinumab - Delayed NSAID Tapering - Treatment Period 2 n=71 participants at risk Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering). Treatment Period 2: from the day of injection at visit Week 16 onwards until study end.	Secukinumab - Early NSAID Tapering - Treatment Period 2 n=70 participants at risk Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering). Treatment Period 2: from the day of injection at visit Week 16 onwards until study end.	Placebo - Treatment Period 2 n=70 participants at risk Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4. Treatment Period 2: from the day of injection at visit Week 16 onwards until study end.
Eye disorders Iridocyclitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Abdominal hernia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Abdominal pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Colitis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Crohn's disease	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Gastritis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Inguinal hernia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Oesophageal ulcer	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Erysipelas	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Renal and urinary disorders Nephrolithiasis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Reproductive system and breast disorders Vaginal cyst	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Psoriasis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).

Other adverse events

Measure	Secukinumab - Delayed NSAID Tapering - Treatment Period 1 n=71 participants at risk Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering). Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study.	Secukinumab - Early NSAID Tapering - Treatment Period 1 n=70 participants at risk Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering). Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study.	Placebo - Treatment Period 1 n=70 participants at risk Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4. Treatment Period 1: from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16). This corresponds to the placebo-controlled period of the study.	Secukinumab - Delayed NSAID Tapering - Treatment Period 2 n=71 participants at risk Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering). Treatment Period 2: from the day of injection at visit Week 16 onwards until study end.	Secukinumab - Early NSAID Tapering - Treatment Period 2 n=70 participants at risk Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering). Treatment Period 2: from the day of injection at visit Week 16 onwards until study end.	Placebo - Treatment Period 2 n=70 participants at risk Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4. Treatment Period 2: from the day of injection at visit Week 16 onwards until study end.
Injury, poisoning and procedural complications Animal bite	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Bone contusion	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Contusion	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Fall	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Hand fracture	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Ligament sprain	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Limb injury	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Muscle injury	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Overdose	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Reactive gastropathy	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Injury, poisoning and procedural complications Wound	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Alanine aminotransferase increased	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Aspartate aminotransferase increased	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Blood glucose increased	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Blood pressure decreased	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Blood pressure increased	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Gamma-glutamyltransferase increased	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Hepatic enzyme increased	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Laboratory test abnormal	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Liver function test increased	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Lymphocyte count decreased	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Red blood cell sedimentation rate increased	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Transaminases increased	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations Weight decreased	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations White blood cell count decreased	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Investigations White blood cell count increased	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Metabolism and nutrition disorders Decreased appetite	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Metabolism and nutrition disorders Pseudohyperkalaemia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Metabolism and nutrition disorders Pseudohypoglycaemia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	4.2% 3/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	8.6% 6/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Arthritis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Back pain	5.6% 4/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Anaemia	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Leukopenia	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Lymph node pain	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Lymphopenia	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Monoclonal B-cell lymphocytosis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Monocytosis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Blood and lymphatic system disorders Neutrophilia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Cardiac disorders Bradycardia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Cardiac disorders Coronary artery disease	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Cardiac disorders Palpitations	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Cardiac disorders Tachycardia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Ear and labyrinth disorders Ear pain	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Ear and labyrinth disorders Tinnitus	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Ear and labyrinth disorders Vertigo	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Endocrine disorders Hyperprolactinaemia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Endocrine disorders Hypothyroidism	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Diplopia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Dry eye	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Eye irritation	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Eye pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Iritis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Macular degeneration	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Presbyopia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Uveitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Eye disorders Visual impairment	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Abdominal pain	4.2% 3/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Abdominal pain upper	4.2% 3/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Aphthous ulcer	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Colitis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Constipation	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Diarrhoea	4.2% 3/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Diarrhoea haemorrhagic	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Dry mouth	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Dyspepsia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Dysphagia	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Enteritis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Frequent bowel movements	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Gastritis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Gingival discomfort	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Haematochezia	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Hiatus hernia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Inguinal hernia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Nausea	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	7.1% 5/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Stomatitis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Gastrointestinal disorders Toothache	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Discomfort	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Fatigue	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Feeling hot	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Impaired healing	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Influenza like illness	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Injection site pruritus	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Injection site urticaria	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Non-cardiac chest pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Oedema peripheral	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Peripheral swelling	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Polyp	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Pyrexia	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
General disorders Thirst	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Hepatobiliary disorders Cholelithiasis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Hepatobiliary disorders Hepatic steatosis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Immune system disorders Allergy to arthropod bite	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Immune system disorders Seasonal allergy	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Bacterial vaginosis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Bronchitis	7.0% 5/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Candida infection	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Conjunctivitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Cystitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Epstein-Barr virus infection	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Erysipelas	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Folliculitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Fungal infection	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Fungal skin infection	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Furuncle	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Gastroenteritis	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	5.7% 4/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Gastroenteritis viral	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Gastrointestinal infection	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Gastrointestinal viral infection	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Herpes simplex	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Infected bite	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Influenza	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Laryngitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Lower respiratory tract infection	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Lyme disease	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Nasopharyngitis	8.5% 6/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	18.6% 13/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	20.0% 14/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	9.9% 7/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	7.1% 5/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Oesophageal candidiasis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Onychomycosis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Oral candidiasis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Oral herpes	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Otitis externa	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Otitis media	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Pharyngitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Pneumonia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Pulpitis dental	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Respiratory tract infection	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	5.7% 4/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Respiratory tract infection viral	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Rhinitis	5.6% 4/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Sinusitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Subcutaneous abscess	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Trichomoniasis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Upper respiratory tract infection	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Urinary tract infection	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Infections and infestations Uterine infection	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Joint swelling	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Muscle tightness	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Rheumatic fever	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Spondyloarthropathy	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Ageusia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Cervicobrachial syndrome	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Disturbance in attention	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Dizziness	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Dysaesthesia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Dysgeusia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Headache	16.9% 12/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	14.3% 10/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	8.6% 6/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	5.6% 4/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Intercostal neuralgia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Migraine	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Nerve compression	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Paraesthesia	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Paresis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Presyncope	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Sciatica	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Tension headache	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Nervous system disorders Tremor	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Psychiatric disorders Apathy	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Psychiatric disorders Depression	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Psychiatric disorders Insomnia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Psychiatric disorders Nervousness	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Psychiatric disorders Restlessness	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Psychiatric disorders Sleep disorder	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Renal and urinary disorders Dysuria	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Renal and urinary disorders Haematuria	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Renal and urinary disorders Proteinuria	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Renal and urinary disorders Renal failure	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Renal and urinary disorders Urinary incontinence	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Reproductive system and breast disorders Menorrhagia	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Reproductive system and breast disorders Uterine pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Respiratory, thoracic and mediastinal disorders Cough	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Dyshidrotic eczema	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Eczema asteatotic	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Erythema	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Guttate psoriasis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	2.9% 2/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Palmoplantar pustulosis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Rash	2.8% 2/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Seborrhoea	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Skin exfoliation	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Skin fissures	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Skin irritation	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Solar dermatitis	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Vascular disorders Circulatory collapse	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Vascular disorders Haematoma	1.4% 1/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Vascular disorders Hypertension	5.6% 4/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	4.3% 3/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	5.7% 4/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).
Vascular disorders Hypotension	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	1.4% 1/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/71 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).	0.00% 0/70 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks). Any signs or symptoms that occurs from first study drug treatment until 30 days after the last study drug treatment. Adverse events were analyzed by treatment period, i.e., Treatment Period 1 from first study drug administration at baseline through Week 16 (concretely: until the day before the injection of study drug scheduled at visit Week 16) and Treatment Period 2 (from the day of injection at visit Week 16 onwards until study end).

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

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

Restriction type: OTHER